Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The HYDROTOPES Category comprises the following 6 substances:
STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)
SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)
NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)
SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)
KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)
NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5) 
In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH.


 


Skin irritation


There are studies available for all the subgroups of Hydrotropes (toluene, cumene and xylene sulphonates) which don’t show any irritating


effect that cause a classification. Regarding the cumene sulphonates, only the sodium salt (SCS) was tested and the available test


will be used for the other two substances in the subgroup, potassium and ammonium salt, since the difference in the type of cation is


not considered to influence the behaviour of the substances.


 


Eye irritation


There are studies available for all the subgroups of Hydrotropes (toluene, cumene and xylene sulphonates) with different results.
Due to the effects seen in some of the existing experimental studies and based on the type of effects, a classification for eye irritation is justified


(Eye Irrit. Cat. 2, H319). Regarding the cumene sulphonates, only for the sodium salt (SCS) was tested and the available test will be used for


the other two substances in the subgroup, potassium and ammonium salt, since the difference in the type of cation is not considered to influence


the behaviour of the substances.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: As described in the U.S. Federal Register Vol. 38, No. 187, Section 1500:41, 1973
Deviations:
not specified
Principles of method if other than guideline:
Shaved skin; abraded and non-abraded; two sites per animal; exposed area covered; oedema and erythema assessed at 24 and 72 hours; primary irritation index evaluated following Draize scoring procedure.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: "recognized breeders"
- Age at study initiation: 14-16 weeks
- Weight at study initiation: 2.3 Kg average
- Housing: caged singularly
- Diet: ad libitum (commercial rabbit diet supplied by Rank Hovis MacDougal)
- Water: filtered water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 °C +/- 2 °C
- Humidity (%): 50-70%- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): natural lighting conditions
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single application; patch removed at 24 hours but no indication of excess material wiped off
Observation period:
24 and 72 hours
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: Two 2.5 cm sites, one abraded and one not abraded- % coverage: no data
- Type of wrap if used: Smith & Nephew Elastic bandage covered entire trunk of animal

STUDY DESIGN
24 hours prior to dermal application, the backs of the rabbits were shaved over an area of at least 10% of the trunk. Two test sites lateral to the mid line of the back were used on each animal. Immediately before the application of the test substance, the right hand site was abraded witht he point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
0.5 ml of the pre—application preparation of the test compound was applied to each test site on a 2. 5 cms square gauze pad, which was secured by adhesive tape.
The entire trunk of the animal was covered with Smith & Nephew Elastic bandage to prevent evaporation of the test material.
After 24 hours the dressing was removed and the intact and abraded si tes were assessed for oedema and erythema.
Readings were again made at the end of a total of 72 hours (4B hours after the first reading).

REMOVAL OF TEST SUBSTANCE- Washing (if done): not indicatedSCORING SYSTEM: J.H. Draize (1959) - primary irritation score (average for erythema and oedema for all six animals)
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritation on intact skin.
Slight erythema (score = 1) in 3 of 6 animals at 24 hours with abraded skin fully reversible in 72 hours.
No oedema observed in any animals.
Other effects:
None reported.
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium toluene 4-sulphonate was assessed following official method U.S. Federal Register Vol. 38, No. 187, Section 1500:41, 1973. The results showed no irritation on intact skin, slight erythema (score = 1) in 3 of 6 animals at 24 hours with abraded skin fully reversible in 72 hours and no oedema observed in any animals.

Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: 1964 US Federal Register
Principles of method if other than guideline:
6 female animals exposed on shaved intact and abraded skin of back; one half of the shaved test site abraded in the manner described by J.H. Draize; single dose initially followed by repeated doses (up to 5 times); occluded; scored for erythema and edema using each rabbit's untreated area of skin as its own control; followed procedures described in 1964 US Federal Register
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 to 3.5 kg
- Housing: caged individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): thermostatically controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
other: first test: distilled water; repeat test: no vehicle (undiluted)
Controls:
other: compared with the corresponding control for each rabbit
Amount / concentration applied:
First test:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL in 1 cm square gauze patch
- Concentration (if solution): dilution of test samples with distilled water to 25%VEHICLE
- Amount(s) applied (volume or weight with unit): no data

Repeat test:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL in 1 cm square gauze patch
- Concentration (if solution): 40% active ingredient tested sample as received
Duration of treatment / exposure:
24 hours for each of 5 repeated single dose applications in both tests
Observation period:
At 24, 48, 72, 96 and 120 hours (each observation was 24 hours following a subsequent repeat dosing)
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: shaved half of back (one half intact skin, the other abraded)
- % coverage: 1 cm square on half of back
- Type of wrap if used: gauze patches secured in place with adhesive tape, occluded with polythene sheet

SCORING SYSTEM:
separate 0 to 4 scores for erythema and edema:No erythema = 0; very slight erythema = 1; well defined erythema = 2; moderate-severe erythema = 3; severe erythema = 4No oedema = 0; very slight oedema = 1; slight oedema = 2; moderate oedema = 3; severe oedema = 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
All the scores were 0 for erythema and oedema on intact and abraded skin.
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium toluene 4-sulphonate was assessed following method 1964 US Federal Register where 6 female animals exposed on shaved intact and abraded skin of back. The results showed no irritation, no erythema and oedema on intact and abraded skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: US Federal Register 1964
Principles of method if other than guideline:
6 female animals exposed on shaved intact and abraded skin of back; one half of the shaved test site abraded in the manner described by J.H. Draize; single dose initially followed by repeated doses (up to 5 times); occluded; scored for erythema and edema using each rabbit's untreated area of skin as its own control; followed procedures described in 1964 US Federal Register
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 to 3.5 kg
- Housing: caged individually
- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): thermostatically controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
other: first test: distilled water; repeat test: no vehicle (undiluted)
Controls:
other: compared with the corresponding control for each rabbit
Amount / concentration applied:
First test:TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL in 1 cm square gauze patch- Concentration (if solution): dilution of test samples with distilled water to 33%VEHICLE- Amount(s) applied (volume or weight with unit): no dataRepeat test:TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL in 1 cm square gauze patch- Concentration (if solution): 30% active ingredient
Duration of treatment / exposure:
24 hours for each of 5 repeated single dose applications in both tests
Observation period:
At 24, 48, 72, 96 and 120 hours (each observation was 24 hours following a subsequent repeat dosing)
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: shaved half of back (one half intact skin, the other abraded)
- % coverage: 1 cm square on half of back
- Type of wrap if used: gauze patches secured in place with adhesive tape, occluded with polythene sheet

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: separate 0 to 4 scores for erythema and edema:No erythema = 0; very slight erythema = 1; well defined erythema = 2; moderate-severe erythema = 3; severe erythema = 4No oedema = 0; very slight oedema = 1; slight oedema = 2; moderate oedema = 3; severe oedema = 4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
0
Irritant / corrosive response data:
All the scores were 0 for erythema and oedema on intact and abraded skin
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline US Federal Register 1964.
The results showed no irritation, no erythema and no oedema observed in any animals.

Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Room temperature is 21°C to 25°C, Humidity is 54%to 89%, Dose is (0.20 g) 200mg
Principles of method if other than guideline:
None
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry,Loudonville,Ohio
- Age at study initiation: na
- Weight at study initiation: 2.1 to 2.5 grams
- Housing: Individually housed in stainless steel cages
- Diet (e.g. ad libitum): Purina Certified Rabbit chow # 5322
- Water (e.g. ad libitum):Water purified by reverse osmosis -ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C to 25°C
- Humidity (%): 54% to 89%
- Air changes (per hr): na
- Photoperiod (hrs dark / hrs light): 12 hour dark and 12 hour light

IN-LIFE DATES: From: 1993-06-22 To: 1993-06-25
Type of coverage:
occlusive
Preparation of test site:
other: Intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200mg of test article

Duration of treatment / exposure:
Three adult New Zealand white rabbits were treated with 200 mg of the test substance on to the intact skin sites with 25 mm Hilltop chamber with cotton pad.After 4 hours exposure period, the expendover tape were removeed and the treated sites were observed for erythema and edema at 4hr, 24 hour 48 hour and 72 hours.
Observation period:
41/2 hour,24 hour, 48 hour and 72 hours.
Number of animals:
Three New Zealand white rabbits.
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk of each animal
- Type of wrap if used: Wrappings of Expandover and Athletic tape was used.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): na
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and Eschar formation:0=no erythema, 1= very slight erythema, 2= slight erythema, 3=moderate to severe erythema, 4=severe erytheama, 4/4 highest possible erythema score
Edema formation:0=no edema, 1=very slight edema, 2=slight edema, 3=moderate to severe edema, 4=severe edema,4/4 =highest possible edema
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
PII 1.33 at 4 hours at erythema and 1.0 at edema intact skin site
PII 1.66 at 24 hours at erythema and 0.0 at edema intact skin site
PII 0.66 at 48 hours at erythema and 0.0 at edema intact skin site
PII 0.0 at 72 hours at erythema and 0.0 at edema intact skin site

 Animal number       Degreeof erythema after (Observation ime)      Degreeof edema after (Observation ime)       Mean >=1.5 <2.3 ?   
   24 hr  48 hr  72 hr  24 hr  48 hr  72 hr  Erythema Edema  

 7803

  1  2  2  0  0  0 YES  NO
         Mean= 1.66         Mean= 0.00       
 7788  0  1  1  0  0  0  NO NO    
         Mean=0.66         Mean= 0.00       
 7789  0  0  0  0  0  0 NO  NO    
         Mean= 0.00         Mean= 0.00       
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium p-cumenesulphonate was assessed following official guideline OECD 404, Acute Derma Irritation/corrosion.
Three New Zealand white rabbits were treated with 200 mg of test substance occlusively. The results showed slight erythema of 2 animals at 24 hr, 48 hr and 72 hours. The skin responses completely resolved by 72 hours reading. No edema were seen in all the animals.

Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Study period:
April 5-8, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Michigan
- Age at study initiation: 7 months
- Weight at study initiation: males 3457-3644g, females 3333-3598g
- Housing: individually in hanging stainless steel wire mesh cages
- Diet: up to 125g per day (certified rabbit Chow)
- Water: ad libitum
- Acclimation period: minimum of 12 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): controlled
- Photoperiod (hrs dark / hrs light): 12/12
- other: Animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication "Guide for the Care and Use of Laboratory Animals".

IN-LIFE DATES: From: April 5 To: April 8
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 31.2% active ingredient

VEHICLE- Amount(s) applied (volume or weight with unit): no vehicle used

OTHER:Test substance was applied to the site under a 1-inch square gauze secured with strips of Dermiform tape over a gauze bandage. A collar was attached to the rabbit
Duration of treatment / exposure:
4 hours followed by bandage removal and the site wiped with dry disposable toweling.
Observation period:
72 hours
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 1 inch square
- Type of wrap if used: gauze bandage with Dermiform tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with dry toweling
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize method
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no irritation observed
Irritant / corrosive response data:
no dermal irritation was observed in any animal during the study period
Other effects:
no other effects observed
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not a dermal irritant
Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12IN

-LIFE DATES: From: 1982-09-07 To: 1982-09-20
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
- Concentration (if solution): 60% in water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after patch removal
Number of animals:
6 (3 male, 3 female)
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, which was covered with a polyethylen film (6 x 6 cm). The application area was then immobilised with an elastic dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE- Erythema: 0- Edema: 0

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score:

Max. score:

60 min

0/0/0/0/0/0

0/0/0/0/0/0

24 h

0/0/0/0/0/0

 0/0/0/0/0/0

48 h

 0/0/0/0/0/0

 0/0/0/0/0/0

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

 0

 0

Reversibility*)

 -

 -

Average time (unit) for reversion

 -

 -

 

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium p-cumenesulphonate was assessed following official guideline OECD 404, Acute Derma Irritation/corrosion. 
The results showed no irritation, no erythema and no oedema observed in any animals.

Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 1.8 - 2.6 kg
- Housing: single housing in stainless steel cages
- Diet: Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: Drinking water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g of the test material was wetted with 0.5 cm³ deionised water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 cm³
Duration of treatment / exposure:
4 hours
Observation period:
up to 6 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, the application area was then immobilised with an elastic dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.33
- Edema: 0

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

0/0/1

0/0/1

24 h

0/0/1

 0/0/0

48 h

0/0/0

0/0/0

72 h

0/0/0 

 0/0/0

Average 24h, 48h, 72h

 0.11

 0

Reversibility*)

 c.

 -

Average time (unit) for reversion

 48 h

 -

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium toluene 4-sulphonate was assessed following official guideline OECD 404, Acute Derma Irritation/corrosion. 
The results showed no irritation on intact skin, slight erythema (score = 0.3) fully reversible in 72 hours and no oedema observed in any animals.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
late 1974 or January 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Principles of method if other than guideline:
6 animals; clipped backs with minor incisions through the stratum corneum; single dose; occluded; 24 hour exposure followed by removal of any remaining test material; reactions scored using the Draize method.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually housed in metal cages elevated above the droppings
- Diet: ad libitum (Purina Rabbit Chow)
- Water : tap water ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded through the stratum corneum but not disturbing the derma
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL- Concentration (if solution): undilutedVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 2 one-inch square patches per animal
- Type of wrap if used: plastic binder and adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize, Woodward and Calvery (J. Pharmacol, Exptl. Therap., 82:377, 1944)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
erythema and eschar average value at 24 hours = 1.3 (intact and abraded skin identical); = 1.2 at 48 hours (intact and abraded identical); = 0.3 at 72 hours (intact and abraded identical);average edema formation value at 24 hr = 1.2 (intact and abraded skin identical); = 0.3 at 48 hours (intact and abraded identical); = 0.0 at 72 hoursPrimary Irritation Index = 1.4
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline Federal Hazardous Substance Act (FHSA). The results showed slight erythema and edema in any animals with reversible effects within 72 hours.

Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Study period:
October 9 - 16, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boswell, S-K & Lomax
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing:individually in metal cages elevated above the droppings
- Diet: ad libitum (Purina Rabbit Chow)
- Water: tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: October 9, 1979 To: October 16, 1979
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL of undiluted test material
- Concentration (if solution): no data

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
24 hours after which the plastic binder and patches were removed and any remaining material was wiped off the treated areas
Observation period:
At 24, 48, 72 and 96 hours and at 7 days following exposure
Number of animals:
6 of random sex
Details on study design:
The backs of the animals were clipped free of hair. Two sets of abrasions (minor incisions through the stratum corneum, but not deep enough to disturbe the derma) were made approximately ten centimeters apart on the right side of the back of each animal, while the skin of the left side remained intact. The animals were immobilized in a restrainer rack and 0.5 mL of the undiluted test substance applied to 2 intact and 2 abraded areas on each rabbit. Patches were first taped in place and then the entire trunk of the animal was enclosed in a plastic binder for 24 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Within 24 hours in all animals there was a barely perceptible to slight erythema and edema. This condition continued in all six animals at 48 hours and in five of six animals at 72 hours and 96 hours. The skin of all animals were reaction free at 7 days.
Other effects:
None reported

See attached tables

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Ammonium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline US Federal Register 1964.
The results showed slight erythema with reversible effects within seven days. No edema were seen in any animals.

Endpoint:
skin irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 2.40 - 2.77 Kg
- Housing: individually housed in steel cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Conditioned for at least 5 days prior to study initiation. Maintained according to the recommendations contained in the "Guide for the Care and Use of Laboratory Animals", National Academy Press, 1996

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): "light controlled"

IN-LIFE DATES: From: August 7, 2007 To: August 10, 2007
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 gram
- Concentration (if solution): undiluted; test substance is 40% active ingredient
VEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
4 hours; after which excess test material was removed from the site
Observation period:
30 minutes and 24, 48 and 72 hours after patches were removed
Number of animals:
3 (females)
Details on study design:
TEST SITE
- Area of exposure: 6 sq cm
- % coverage:
- Type of wrap if used: 2 layer gauze patch covered with semiocclusive plastic overwrop held in place with Kendall Curity Standard Porous Tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess removed
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The maximum skin irritation score was 1.0 at the 4.5 hour observation.
The primary irritation score Index (4.5, 24, 48 and 72 hours) = 0.25
Other effects:
Final body weights were within expected values.

See attached table

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant
Executive summary:

The skin irritation of Sodium p-cumenesulphonate was assessed following official guideline OECD 404, Acute Dermal Irritation/corrosion. 
The results showed no irritation, no erythema and no oedema in any animals.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-10-10 To: 1989-10-31
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, and 6, 8, 10, 13, 17 and 21 days after application
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 72 hours after administration
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days (1 animal)
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 days (1 animal)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days (1 animal)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
AVERAGE SCORE (24, 48 and 72 h)
- Cornea: 2.0
- Iris: 1.0
- Conjunctivae (Redness): 3.0
- Conjunctivae (Chemosis): 2.33
Other effects:
Dark red erythema, strong swelling and necrotic variations of mucosa and nictitating membrane, all animals. Opacity and hemorrhage on iris, up to 6 days on two animals; strong opacity and strong circumcorneal injection of iris on day 21 still on one animal.
The test item had a moderately irritating effect on the eyes.1 of 3 animals showed irreversible damages at cornea, iris and conjunctivae.

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

1/2/2

 1/0/0

 2/3/2

 3/2/2

24 h

2/2/2

 1/1/1

 3/3/3

 2/3/2

48 h

 2/2/2

 1/1/1

 3/3/3

 2/2/2

72 h

 2/2/2

 1/1/1

 3/3/3

 2/2/2

Average 24h, 48h, 72h

 2.00

 1.00

 3.00

 2.11

Area effected

1.44

 -

 -

 -

Reversibility*)

 n.

 n.

 n.

 n.

Average time (unit) for reversion

-

 -

 -

 -

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Irritant
Executive summary:

The eye irritation of Sodium Toluene-4 sulphonate was assessed following official guideline OECD 405, Acute Eye Irritation/Corrosion.
Dark red erythema, strong swelling and necrotic variations of mucosa and nictitating membrane, all animals. Opacity and hemorrhage on iris, up to 6 days on two animals; strong opacity and strong circumcorneal injection of iris on day 21 still on one animal.
The test item had a moderately irritating effect on the eyes.1 of 3 animals showed irreversible damages at cornea, iris and conjunctivae.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Version / remarks:
Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, Food and Drug Officials of the US, 2nd printing, Topeka, Kansas, 1965. In accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act
Principles of method if other than guideline:
6 animals; eyes examined with Fluorescein 72 hours before testind; test substance instilled into the conjuntival sac of one eye in each animal; washedout at 24 hours; evaluated at 1, 24, 48 and 72hours
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually housed in metal cages elevated above the droppings
- Diet: ad libitum (Purina Rabbit Chow)
- Water : tap water ad libitum
- Acclimation period: at least 72 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single application, washed out after 24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing at 24 hours

SCORING SYSTEM: scale for scoring ocular lesions as outlined by Lehman et al (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, Food and Drug Officials of the US, 2nd printing, Topeka, Kansas, 1965. In accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
5
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Maximum mean total score at 1 hr = 13.0, at 24 hr = 12.2, at 48 hr = 5.0 and at 72 hr = 2.0
Slight eye damage in the form of moderate erythema of the palpebral and bulbar conjunctivae, a slight chemosis of the lids, a slight acccumulation of mucoid discharge and a slight to moderate corneal opacity involving one-fourth or less of the corneal surface (4 test eyes only).

See attached table

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Irritant
Executive summary:

The eye irritation of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, in accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act. The results showed slight eye damage in the form of moderate erythema of the palpebral and bulbar conjunctivae, a slight chemosis of the lids, a slight acccumulation of mucoid discharge and a slight to moderate corneal opacity involving one-fourth or less of the corneal surface (4 test eyes only).

Endpoint:
eye irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act (FHSA)
Version / remarks:
Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, Food and Drug Officials of the US, 2nd printing, Topeka, Kansas, 1965. In accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act
Principles of method if other than guideline:
Test material instilled undiluted into the conjunctival sac of six rabbits. The eyes of some treated animals were not washed following exposure and other animals had their eyes washed after 20 seconds of exposure. Exposure was followed by 14 days of observation and the grade of occular reaction, based on the scoring scale of Lehman et al 1965 (US FDA), recorded at prescribed intervals. A maximum average score for washed and unwashed eyes was calculated.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SLK, Per-DOT, Issac's
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in metal cages elevated above the droppings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):no data

IN-LIFE DATES: From:April 23, 1979 To: May 7, 1979
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL in one eye of each animal (the other eye was not treated and served as a control)
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
6 of the 9 animals were treated and their eyes were not washed. The remaining 3 animals had their eyes washed for one minute following 20 seconds of exposure.
Observation period (in vivo):
All animals (both eyes) at 1, 24, 48, 72 and 96 hours; and at 7, 10 and 14 days
Number of animals or in vitro replicates:
9 total; six with eyes not washed and 3 with eyes washed
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of 9 animals. One minute washing.
- Time after start of exposure: 20 seconds
- All animals were immobilized in a suitable restrainer rack for one hour following treatment

SCORING SYSTEM: scale for scoring as outlined by Lehman, A.J. et al. in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, 1965.TOOL USED TO ASSESS SCORE: fluorescein sodium 2% on the cornea
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks:
7 days
Irritant / corrosive response data:
Rabbits with treated eyes that were not washed produced within 24 hours conjunctival lesions in the form of a moderate erythema of the palpebral and bulbar conjunctivae, a slight to moderate chemosis of the lids, a slight to moderate watery-mucoid discharge and a slight corneal opacity (4 of the 6 animals) involving one-fourth of less of the corneal surface. The test eyes showed steady improvement with the cornea of all test eyes being reaction free at 72 hours. A maximum average score of 13.7 was recorded at 24 hours.The rabbits with washed eyes following treatment produced within 24 hours conjunctival lesions in the form of a slight erythema of the palpebral and bulbar conjunctivae, a moderate chemosis of the lids, a slight watery-mucoid discharge and a slight corneal opacity involving one-fourth to one-half of the corneal surface. Little change was noted at 48 hours and some deduction of the reaction was noted at 72 hours. The corneal reaction was not present at 96 hours and all test eyes were reaction free by 10 days. A maximum average score of 17.3 was recorded at 48 hours.
Other effects:
None reported
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Irritant
Executive summary:

The eye irritation of Ammonium (xylenes and 4-ethylbenzene) sulfonates was assessed following official guideline Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, in accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances Act. The results showed effects on eye. Rabbits with treated eyes that were not washed produced within 24 hours conjunctival lesions in the form of a moderate erythema of the palpebral and bulbar conjunctivae, a slight to moderate chemosis of the lids, a slight to moderate watery-mucoid discharge and a slight corneal opacity (4 of the 6 animals) involving one-fourth of less of the corneal surface. The test eyes showed steady improvement with the cornea of all test eyes being reaction free at 72 hours. A maximum average score of 13.7 was recorded at 24 hours. The rabbits with washed eyes following treatment produced within 24 hours conjunctival lesions in the form of a slight erythema of the palpebral and bulbar conjunctivae, a moderate chemosis of the lids, a slight watery-mucoid discharge and a slight corneal opacity involving one-fourth to one-half of the corneal surface. Little change was noted at 48 hours and some deduction of the reaction was noted at 72 hours. The corneal reaction was not present at 96 hours and all test eyes were reaction free by 10 days.  A maximum average score of 17.3 was recorded at 48 hours.

Endpoint:
eye irritation: in vivo
Type of information:
other: Read across from another member of the category
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kuiper RAbbitry, Gary, Indiana- Age at study initiation: 8-10 weeks- Weight at study initiation: 2.59-2.66 kg- Housing: individually in steel cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period: conditioned for at least 5 days prior to study. Animals were maintained according to "Guide for the Carre and Use of Laboratory Animals", National Academy Press, 1996. ENVIRONMENTAL CONDITIONS- Temperature (°C): 16 - 22- Humidity (%): 30-70- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): "light controlled room"IN-LIFE DATES: From: August 7, 2007 To: August 14, 2007
Vehicle:
unchanged (no vehicle)
Controls:
other: unexposed eye of each animal served as its own control
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit):0.1 gram- Concentration (if solution): undiluted is 40% active ingredientVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single dose (no washing)
Observation period (in vivo):
at 1, 24, 48 and 72 hours and at 7 days
Number of animals or in vitro replicates:
3 (males)
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): no washingSCORING SYSTEM: DraizeTOOL USED TO ASSESS SCORE: fluorescein (2%) and ultraviolet light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The maximum irritation (noted as "moderate") occurred at 24 hours, with effects observed in the cornea, iris and conjunctiva of all three animals. The scores were noticeably lower at 48 hours and again at 72 hours. No irritation was detected at 7 days.
Other effects:
Final body weights were within expected range.

See attached tables

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Irritant
Executive summary:

The eye irritation of Sodium p-cumenesulphonate was assessed following official guideline OECD 405, Acute Eye Irritation/Corrosion.
The maximum irritation occurred at 24 hours, with effects observed in the cornea, iris and conjunctiva of all three animals.  The scores were noticeably lower at 48 hours and again at 72 hours. No irritation was detected at 7 days.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin irritation: Based on the available skin irritation studies no classification for skin effects is warranted.

Eye irritation: The effects observed in the available eye irritation studies vary from slightly to moderately irritating. In only one of the available studies were the effects shown not to be reversible (in one single animal after 21 days). In all other studies the effects were observed to be reversible in all animals. Therefore based on data across the category members, a classification as "Eye irritant, category 2, H319" is justified.