Registration Dossier

Administrative data

Description of key information

SKIN

In a primary skin irritation study, the test substance was identified as not irritant to the skin (BASF AG, 77/148, 1978). This result was confirmed by two supporting studies (TSCA OTS0001087, 1987).

EYE

In a primary eye irritation study, the test substance was identified as not irritant to the eye (BASF AG, 77/148, 1978). This result was confirmed by two supporting studies (TSCA OTS0001087, 1987A and 1987B).

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:
guideline study with acceptable restrictions
Remarks:
non-GLP, occlusive coverage, no washing after 24 h exposure
Principles of method if other than guideline:
Before OECD Guideline 404 was established in 1982, skin irritation was tested according to the acknowledged Draize test method.
An amount of 0.5 mL of test material was applied to a skin area of 2.5 x 2.5 cm under occlusive conditions for 24 hours. The application site was either intact or scarified. The application site on the intact skin was located dorsally whereas scarified skin was located on the left side. Skin findings were assessed after 24 hours, 48 hours, 72 hours and after 8 days. The assessment of the findings was based on the Federal Reg. 38, No. 187, Para. 1500.41, page 27029 (1973).
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.50 kg
- Diet: Sniff
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
Concentration: 50 %
Duration of treatment / exposure:
24 h
Observation period:
8 d
Number of animals:
6 (4 male, 2 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
evaluation of erythema after 24 h not possible due to treatment related staining.
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Intact skin: Evaluation of erythema after 24 h not possible due to treatment related staining. No oedema or erythrema noted during the entire evaluation period.

Abraded skin: Evaluation of erythema after 24 h not possible due to treatment related staining. After 72 h questionable to slight erythema in 3/5 animals (1 animal evaluation impossible due to substance-related staining); scaling in 4 animals after 8 d. Edema: no effects

Interpretation of results:
GHS criteria not met
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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested according to Federal Register 38, No. 187, § 1500.42, S. 27019, 27. Sept. 1973
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.50 kg
- Diet: Sniff
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 µL
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (3 male/3 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed


SCORING SYSTEM: Draize
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility unclear in 2/6 animals
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility unclear
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility unclear
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
Secretion was not observed.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

SKIN

For the determination of the skin irritation/ corrosion potential, data from three in-vivo studies are available. One pre-GLP study was performed according to the Draize test (BASF AG, 77/148, 1978). Erythema and oedema were not observed in six rabbits after occlusive dressing for 24 hours of exposure. This result was confirmed by two supporting non-GLP studies (TSCA OTS0001087, 1987), where no skin-irritating potential of the test substance could be identified.

EYE

For the determination of the eye irritation potential, data from three in-vivo studies are available. One non-GLP study was performed according to Federal Register 38, No. 187, § 1500.42 (Draize test: 24 h exposition under occlusive conditions) (BASF AG, 77/148, 1978). No Cornea opacity, iritis and chemosis were observed in any of the 6 animals. Conjunctivae redness was slight but not completely reversible within 72 h in 2/6 animals, as the study was terminated. It can be expected that the slight conjunctival redness would be fully reversible after 21 days. The low eye irritating potential of the test substance is corroborated by two supporting non-GLP studies (TSCA OTS0001087, 1987). No test substance related irritating effects on cornea, iris or conjunctivae were noted on the unrinsed eye. One of the supporting studies was conducted according to US EPA §163.81 -5, 1978.

CONCLUSIONS

The study data on skin and eye irritation reveal no test substance related adverse effects.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance does not need to be classified and labelled as skin or eye irritating under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.