Registration Dossier

Administrative data

Description of key information

SKIN

rabbit, 24 h, occlusive: not irritant (Draize, BASF AG, 1978)

EYE

rabbit, 100 µL, unwashed: no indication for an eye irritation (Fed. Reg. 38, No. 187, § 1500.42, BASF AG, 1978)

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: Comparable to guideline study with acceptable restrictions (non-GLP, occlusive dressing, no washing after 24 h of 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 the area of 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 hours
Observation period:
8 days
Number of animals:
6 (2 males, 4 females)
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:
other: 24/72 h/8 d
Score:
0
Max. score:
4
Remarks on result:
other: Evaluation of erythema after 24 and 72 hours not possible due to substance related staining. No erythrema noted at day 8.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h

Abraded skin:

Evaluation of erythema impossible after 24 and 72 h due to colouring of skin, no erythema after 8 days but scaling in 3/6 rabbits. Edema in 4/6 rabbits after 24 h, no edema after 72 h or 8 d.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Observation period shorter than described in OECD Guideline 405
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:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.4 kg
- Diet: Sniff
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
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:
0.83
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility unclear in 3/6 animals
Irritation parameter:
conjunctivae score
Basis:
animal #1
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 #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:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility unclear
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
Secretion was observed in four and one animal after 24 and 48 hours, respectively.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN

For the determination of the eye irritation potential, two non-GLP studies are available. One of the two studies was performed according to Federal Register 38, No. 187, § 1500.41, S. 27019, 27. Sep. 1973 (BASF AG, 77/146, 1978). Erythema was not observed and slight oedema was reversible within 72 hours in six rabbits after occlusive dressing after 24 hours of exposure. The conclusion that the test substance is not irritating to the skin was supported by an additional study from a secondary source (Bayer, 1979).

EYE

For the determination of the eye irritation potential, two non-GLP studies are available. One of the two studies was performed according to Federal Register 38, No. 187, § 1500.42 (Draize test: 100 µL, unwashed eyes) (BASF AG, 77/146, 1978). Corneal opacity, iritis and chemosis were not observed in any of the 6 animals. Slight conjunctival redness was not completely reversible within 72 h, as the study was terminated but full reversibility of slight conjunctival redness can be expected after 7 to 21 days. This is supported by the data of an additional study from a secondary source, which leads to the conclusion that the test substance is not irritating to the eye (Bayer, 1979). For the sake of animal welfare, further animal testing is not deemed necessary.

CONCLUSIONS

The study data on skin and eye irritation reveal 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 irritant under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.