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Diss Factsheets

Administrative data

Description of key information

Skin irritation in vivo: slightly irritating (BASF, 1982)
Eye irritation in vivo: not irritating (BASF, 1982)

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:
1981-07-21 to 1981-07-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.41, 1973 (Draize test)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Weight at study initiation: males: 2.44 kg; females: 2.57 kg
- Housing: individually (stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm)
- Diet: ad libitum, Ovator Solikanin 4 mm (Muskator-Werke Düsseldorf, FRG); about 130 g per animal per day
- Water: ad libitum, fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimation period: about 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flank
- coverage: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
Test substance was not washed off.

SCORING SYSTEM
According to J.H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 8 days (in 3/6 animals)
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
Symptoms observed after 24 hours (intact and abraded skin) were erythema and edema - extending beyond the area of exposure. After 8 days (intact and abraded skin) all animals showed scaling of the skin but no erythema or edema (all but one). One animal still showed slight redness of the skin with scaling.
Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
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:
1981-07-14 to 1981-07-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
according to Fed. Reg. No. 38, No. 187, § 1500.42, 1973 (Draize test)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Weight at study initiation: males (mean): 2.3 kg; females (mean): 2.79 kg
- Housing: individually (Cage made of stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm)
- Diet: ad libitum, Ovator Solikanin 4 mm (Muskator-Werke Düsseldorf, FRG); about 130 g per animal daily
- Water: ad libitum, fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimation period: about 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
Test substance was not washed out of the treated eye.

SCORING SYSTEM
According to J .H . Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity, pp. 46 - 59, 1959. Austin Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health
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:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
A slight and reversible redness of the conjunctivae was observed in all but one animal.
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 irritation


Following the experimental design according to Federal Register 38, No. 187, § 1500.41, S. 27019, 27. Sept. 1973 0.5 mL of the test substance was applied undiluted to the intact and abraded skin of six rabbits (BASF, 1982). The application to the intact skin resulted in slight erythema in all animals after 24 hours. One animal exhibited severe oedema and 3/6 animals showed slight oedema. The oedema of the remaining two animals was regarded as questionable. After 72 hours slight erythema was still observed in all but one animal (slight erythema had changed to severe). Oedema was questionable to slight among the animals (3/6 questionable oedema; 3/6 slight oedema). No erythema or oedema was observed in all animals but one after 8 days. One animal still showed questionable erythema at the end of the study period. All animals showed scaling at the end of the study. Thus the test substance is regarded as slightly irritating to the skin.


Eye irritation


Following the experimental design according to Federal Register 38, No. 187, § 1500.42, S. 27019, 27. Sept. 1973, 0.1 mL of the test substance was instilled in the conjunctival sac of six Vienna white rabbits (BASF, 1981). The eyes were not washed after 24 hours of exposure. Animals were observed for 8 days. Irritation was scored by the method of Draize et al.. Very slight and reversible redness of the conjunctivae was observed. No other irritating effects were seen in the test animals. The test substance is not considered as irritating to the eyes.

Justification for classification or non-classification

 


Classification, Labelling, and Packaging Regulation (EC) No 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified according to Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.