Registration Dossier

Administrative data

Description of key information

Skin irritation: Slightly irritating (Target substance and source substances)
Eye irritation: Not irritating (Target substance and source 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:
experimental study
Adequacy of study:
key study
Study period:
1989-05-09 to 1989-05-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Witamol 118
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 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): 12/12
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 cm³
Duration of treatment / exposure:
4 hours
Observation period:
up to 7 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
- % coverage: not mentioned
- 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:
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
Max. score:
4
Reversibility:
fully reversible
Remarks:
after 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 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.0
- Edema: 0.0
Other effects:
none

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

0/1/0

 0/0/0

24 h

1/1/1

 0/0/0

48 h

 1/1/1

 0/0/0

72 h

 1/1/1

 0/0/0

Average 24h, 48h, 72h

 1.0

 0

Reversibility*)

 c.

 -

Average time (unit) for reversion

 7 days

 -

 

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

 

Interpretation of results:
GHS criteria not met
Executive summary:

1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was only slightly irritating.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
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:
experimental study
Adequacy of study:
key study
Study period:
1989-05-23 to 1989-05-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Witamol 118
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
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: 2.4 - 2.5 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
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, and 6 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm phyiological saline
- Time after start of exposure: 72 hours


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 hours after administration
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.11
- Conjuntivae (Chemosis): 0.0
Other effects:
Minimal to slight discharge was observed in two animals only one hour after application.

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

0/0/0

 0/0/0

 1/1/1

 0/0/0

24 h

 0/0/0

 0/0/0

 0/1/0

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

 0.11

 0

Area effected

 

 

 

 

Maximum average score (including area affected, max 110)

 

 

 

 

Reversibility*)

 -

 -

 c.

 -

Average time (unit) for reversion

 -

 -

 48 hours

 -

 

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

 

Interpretation of results:
GHS criteria not met
Executive summary:

1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was not eye irritating.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The target substance 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was only slightly irritating to the skin. Also source substances were only slightly skin irritant. An assessment of dermal irritation of various phthalate esters in the rabbit following test methods resulted in no or only very slight erythema.

The target substance 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was not eye irritating. The potential for eye irritation was assessed in various studies on several structurally related phthalic acid esters. No or only slight conjunctival reactions were observed following instillation into the conjunctival sac of the eye.


Justification for classification or non-classification

The target substance and the source substances were tested to be slightly skin and not eye irritating. Hence the test substance is not classified according to Regulation (EC) No 1272/2008.