Registration Dossier

Administrative data

Description of key information

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid is slightly irritating to the skin of rabbits (OECD 404, Hüls 1985) and not irritating to eye and mucosa of rabbits (OECD 405, Hüls 1985), which does not meet the criteria according to EC regulation 1272/2008 to be classified as "irritating to skin and eyes".

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:
1985-11-23 to 1985-12-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Guideline study; in deviation from OECD TG 404 occlusive dressing was used.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
occlusive dressing
GLP compliance:
no
Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals and environmental conditions:
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.7 kg - Environmental conditions:
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
Air change: 15 times/hour;
Light: 12 hour light/dark rhythm;
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
water: tap water ad libitum
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL test item
Duration of treatment / exposure:
4 hour(s)
Observation period:
- Post exposure observation period: 8 days
- Observations at 1, 24, 48, 72 hours, 6, 9, 12 and 14 days after administration of the test substance
Number of animals:
3 males, 3 females
Details on study design:
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing for 4 hours
- Removal of test substance: washing with warm water
- Scoring system: according to Draize
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1; 24; 48; 72 h
Score:
1.67
Max. score:
8
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0.39
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.33
- Edema: 0.39
- Irritation index: 1.67/8
Other effects:
no further information

To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales. For details see attached table.

Conclusions:
According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.
Executive summary:

To test the acute skin irritant effect of the test item

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid

was applied to the shaven dorsal skin of rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.

To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales.

According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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:
1985-11-21 to 1985-11-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.0 - 2.5 kg - Environmental conditions:
room temperature: 20°C (+/- 1°C)
humidity: 60% (+/- 5%)
Air change: 15 times/hour
Light: 12 hour light/dark rhythm
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany)
water: tap water ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, left eyes remained untreated
Amount / concentration applied:
0.1 mL undiluted test item
Duration of treatment / exposure:
72 hours after application, the treated eyes were rinsed with warm physiological saline
Observation period (in vivo):
- Postexposure observation period: 6 days
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6 days after treatment
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
- Tool used to assess score: Na fluorescein / ophthalmic lamp / visual inspections
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1; 24; 48; 72 h
Score:
1.42
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0.06
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0.06
- Conjuntivae (Chemosis): 0
- Overall irritation score: 1.42/110
Other effects:
no further information

A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.

Conclusions:
According to results of the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.
Executive summary:

To test the acute irritant effect on eyes and mucosa of the test item

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid

lauryl lactam was administered undiluted into eyes or eyelid sacs of male and female rabbits.

A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.

According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Justification for classification or non-classification

Based on the assessment of two animal studies (skin and eye irritation) and according to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid

is not irritating to skin and eyes.