Registration Dossier

Administrative data

Description of key information

The substance is considered to be not irritating to the skin but induces irreversible effects on the eye

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.
Qualifier:
no guideline followed
Principles of method if other than guideline:
According to BASF-internal standard. Two rabbits (1 male, 1 female) were dermally exposed to the test substance followed by a 8 day observation period. Test areas where the back and the ear of the rabbit.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
- Weight of female animal: 2.93 kg
- Weight of male animal: 3.4 kg
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
about 1 g of a 50 % aqueous preparation
Duration of treatment / exposure:
1, 5, and 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: The back of the animals
- Application area: 2.5 x 2.5 cm:
- Type of wrap if used: Cotton pad for the back of the animals

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol 50%
- Time after start of exposure: 20 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1 and 2
Time point:
other: 24, 48, 72
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20 hours exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1 and 2
Time point:
other: 24, 48, 72
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20 hours exposure
Irritant / corrosive response data:
Also no effects observed after 1, 5, and 15 minute exposure.
Other effects:
None
Interpretation of results:
not irritating
Remarks:
Migrated information
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.
Qualifier:
no guideline followed
Principles of method if other than guideline:
According to BASF-internal standard. Two rabbits (1 male, 1 female) were exposed to the undiluted test substance in the eye followed by a 8 day observation period.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- Weight of female animal: 2.76 kg
- Weight of male animal: 2.96 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of the same animal
Amount / concentration applied:
ca. 50 mg
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
The test substance was not washed out.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: control eye also showed effects on conjunctiva (reversible after 72 h)
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: control eye also showed conjuctiva effects up to 8 days after substance application
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
1.67
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Blood was observed in the exposed eye of animal one at 1 hour after exposure, but was absent thereafter
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

To assess the skin irritating potential of the test substance, two rabbits (1 male, 1 female) were dermally exposed to the test substance for 20 hours followed by a 8 day observation period. No effects were observed on the exposed areas on the back of both animals. No additional effects were reported. Based on these results the test substance is considered to be not irritating.

Eye irritation / corrosion

To assess the eye irritating potential of the test substance, two rabbits (1 male, 1 female) were exposed to the undiluted test substance in the eye followed by a 8 day observation period and effects were determined 24, 48, 72 hours and 8 days after exposure. Exposure resulted in slight conjunctival redness in both animals after 24 hours (score = 1). This effect was in one of the animals not fully reversible within 8 days. However, it has to be noted that the control eye, which was terated with talcum, also showed conjuctival redness after 24 h and 8 days, indicating that the irreversibility of conjunctival effects should not be considered as classification criteria. One animal showed slight (score = 1) and one animal showed marked chemosis (score = 2) after 24 hours. While chemosis disappeared in the first animal at 48 h, chemosis was still observed at 48 and 72 h in the second animals, but was then absent at day 8 (fully reversible in both animals). Slight corneal opacity was visible in the first animal at 24 h, but was reversible by 48 h. In contrast, marked corneal opacity (score 2) was observed up to 48 h and was the still present as slight corneal opacity (score 1) at 72. This effect was not reversibel by day 8.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the absence of effects after skin exposure, classification for skin irritation / corrosion is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

Irreversible effects on corneal opacity were observed in one animal. Since the observation time was only 8 days and it cannot be conclusively shown that these effects will be reversible after 21 days, as a worst case assumption the test subsatcne is classified as H318, Eye category 1 in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.