Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - June 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Information from study report:
- Name of test material: Emulgator E30, Fest
- CAS number: 5896-54-8
The CAS number in report (5896-54-8) is misleading, since this CAS number does only represent 1-Penta-decanesulfonic acid, sodium salt (1:1), but it is confirmed that the substance used is correctly assigned to CAS 68188-18-1.
- Appearance/Further information: The test substance was supplied as white wax-like leaf-let and was received at the test institute on March 06, 1991.
- Batch No. of test material: 210291
- Purity: 95 %
- Analysis reference: TGL 39237
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: NZW rabbits
- Sex: male
- Source: Thomae, Biberach, Germany
- Weight at study initiation (mean): 2.5 kg ± 0.047
- Housing: singly in steel wire cages
- Diet and water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 28 - 41
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
500 g
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
One day before the application the fur was carefully removed by shaving an area approximately 10 x 20 cm of the dorsal trunk.
On day of application 0.5 g of the test substance was placed on a 2 x 3 cm gauze patch and wetted for one hour with 0.4 mL water (Ampuwa, Fresenius, Bad Homburg) to make the emulgator soft. This patch was then positioned on the rabbit so that the test substance was in contact with the shaved skin, just left of the dorsal midline. The patch was held in place by a wrapping of gauze which was secured and semioccluded by a wrapping of blendderm and Leukoplast. After a 4-hour exposure period, wrappings were removed and the test substance was gently washed away with water.

SCORING SYSTEM: Draize
The treated area was scored 0.5, 1, 6, 24, 48, and 72 hours after patch removal, and then periodically until day 14.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
not fully reversible within: 14 days. A slight redness(score 1) was still present by Day 14.
Remarks on result:
other: mean score: 2.7; at 48 and 72 h leathery and red skin was reported
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: at 48 and 72 h leathery and red skin was reported
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: mean score: 2.7; at 72 h leathery skin was reported
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: mean score: 0.3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: mean score: 0.7
Irritant / corrosive response data:
The substance caused initial slight to mild erythema of the treated skin, progressing to moderate erythema in all rabbits by 48 hours after treatment. The severity of the redness decreased slowly thereafter, but was in one animal still present as a slight redness by study day 14. All rabbits also exhibited slight to mild oedema during the first four days.
Other effects:
No animal died during the observation period of 14 days. In all animals, the body weight development was apparently normal, unaffected by treatment. No adverse clinical observations were made in any animal. At necropsy, all animals were essentially normal.
Executive summary:

In a skin irritation/corrosion study according to OECD TG 404 the test substance was applied under semiocclusive dressings for 4 hours to the previously shorn skin of three male rabbits. The treated areas were assessed after 0.5, 1, 6, 24, 48, and 72 hours and then periodically until Day 14 using the Draize scale. The substance caused local irritation of exposed skin, but no evidence of systemic toxicity. In detail, the substance caused initial slight to mild erythema of the treated skin, progressing to moderate erythema in all rabbits by 48 hours after treatment. Additionally for some time points leathery and red skin was reported. The severity of the redness decreased slowly thereafter, but was still present in one animal as a slight redness by study day 14. All rabbits also exhibited slight to mild oedema during the first four days. Mean erythema scores after 24, 48 and 72 hours were 3 (1/3 rabbits) and 2.7 (2/3 rabbits), mean edema scores were 0, 1.3, and 1.7 (each 1/3).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sept - Oct 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Information from study report:
- CAS number 68188-18-1
- Appearance/Further information: white to yellow solid, pH 9.3 (saturated aqueous solution)
- Batch number: Pa. 268, DZA-UER-9000555-A
- Purity: 95 % (Mono-, Di- and Polysulfonate), content of organically bound chlorine 0.6 %
- Analysis Ref.: A89/0184/00 UER
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: females
- Strain: HC:NZW
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England, UK
- Weight at study initiation: 3.0-3.9 kg
- Housing: individually in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions
- Diet and water: ad libitum
- Acclimation period: at least 14 days in the quarantine station

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): approx. 50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The second eye of each rabbit remained untreated and served as control.
Amount / concentration applied:
100 µl eq. to approx. 70 mg
Duration of treatment / exposure:
After instillation of the test substance into the conjunctival sac the eye-lids were gently held together for about one second in order to limit loss of the material. 24 hours after instillation the eye was rinsed with physiological saline.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
After gently pulling the lower lid away from the eyeball a volume of 100 µL of the pulverized test substance, eq. to approx. 70 mg, was instilled into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material.

REMOVAL OF TEST SUBSTANCE
24 hours after instillation of the test substance the treated eye was rinsed with physiological saline.

SCORING SYSTEM: Draize
Eye irritation was scored 1, 24, 48, and 72 hours after administration and after 7, 14, and 21 days.

TOOL USED TO ASSESS SCORE:
The examinations were facilated using optical instruments (e.g. hand slit-lamp). To define epithelial damage, one drop of a 1% fluorescein solution was applied to the cornea surface 24 hours after administration of the test substance; where positive effects were recorded this was repeated at the later observation times. The eye was then rinsed with physiological sodium chloride solution to remove excess and nonabsorbed fluorescein. Evaluation was performed by means of ultraviolet illumination (area) in a darkened room and diffuse white illumination (intensity).
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score: 1.3
Irritation parameter:
iris score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean score: 0.3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: mean score: 0.3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: mean score: 0.7
Irritant / corrosive response data:
Application of the test substance resulted in slight irritant reactions on eyes. Effects proved to be fully reversible on day 7.
Other effects:
not noted
Executive summary:

In an eye irritation/corrosion study according to OECD TG 405 the test substance was instilled into the conjunctival sac of one eye of 3 female rabbits. 24 hours after instillation the eye was rinsed with physiological saline. Eye irritation was assessed after 1, 24, 48, and 72 hours and after 7, 14 and 21 days using the Draize scale. Application of the test substance resulted in slight irritant reactions on eyes (mean scores after 24, 48 and 72 hours: cornea 0 for 1/3 and 1.3 for 2/3 animals, iris 0 for 2/3 and 0.3 for 1/3 animals, conjunctivae/redness 2 for 3/3 animals, chemosis 0, 0.3, and 0.7 for each 1/3 animals). Effects proved to be fully reversible on day 7. Effects other than ocular ones were not noted.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a skin irritation/corrosion study according to OECD TG 404 the substance was applied under semiocclusive dressings for 4 hours to the previously shorn skin of three male rabbits. The treated areas were assessed after 0.5, 1, 6, 24, 48, and 72 hours and then periodically until Day 14 using the Draize scale. The substance caused local irritation of exposed skin, but no evidence of systemic toxicity. In detail, the substance caused initial slight to mild erythema of the treated skin, progressing to moderate erythema in all rabbits by 48 hours after treatment. Additionally for some time points leathery and red skin was reported. The severity of the redness decreased slowly thereafter, but was still present in one animal as a slight redness by study day 14. All rabbits also exhibited slight to mild oedema during the first four days. Mean erythema scores after 24, 48 and 72 hours were 3 (1/3 rabbits) and 2.7 (2/3 rabbits), mean edema scores were 0, 1.3, and 1.7 (each 1/3).

A second study on skin irritation/corrosion with the substance revealed a slightly lower skin irritant potential.

In an eye irritation/corrosion study according to OECD TG 405 the test substance was instilled into the conjunctival sac of each one eye of 3 female rabbits. 24 hours after instillation the eye was rinsed with physiological saline. Eye irritation was assessed after 1, 24, 48, and 72 hours and after 7, 14 and 21 days using the Draize scale. Administration of the test substance resulted in slight irritant reactions on eyes. Effects proved to be reversible on day 7. The mean scores after 24, 48 and 72 hours were: cornea - 1/3 animals score 0 and 2/3 animals score 1.3, iris - 2/3 animals score 0 and 1/3 animals score 0.3, conjunctivae (redness) - 3/3 animals score 2, chemosis - each 1/3 animals score 0, score 0.3, and score 0.7.

A second study using only one animal confirmed that the substance has an irritant potential to the eye.

There are no data available to assess a possible respiratory irritant effect.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, the substance is classified for skin irritation as Cat. 2 (H315: Causes skin irritation) and for eye irritation as Cat. 2 (H319: Causes serious eye irritation).