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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin 
rabbit, semiocclusive, 4 h: not irritant (OECD 404; BASF 1985a, 1985b) 
Eye 
rabbit, 100 µL, unwashed: not irritant (OECD 405; BASF 1985a, 1985b)

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: Guideline study with acceptable restrictions (purity unknown, non-GLP)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.28 kg (males) and 2.31 kg (females)
- Housing: 1 per cage (Stainless steel cages with wire mesh walk floors)
- Diet: Kliba 341, approx. 130 g/d
- Water: tap water, approx. 250 ml/d
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration (if solution): 50% in aqueous solution
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 * 2.5 cmof the upper third of the back or flanks


REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)


SCORING SYSTEM: OECD/ Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Interpretation of results:
GHS criteria not met
Conclusions:
Following the conditions of the test: No classification as skin irritant according to EU and 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (purity unknown, non-GLP)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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: 2.89 kg (males) and 2.70 kg (females)
- Housing: 1 per cage (Stainless steel cages with wire mesh walk floors)
- Diet: Kliba 341, approx. 130 g/d
- Water: tap water, approx. 250 ml/d
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Controls:
other: The untreated eye served as negative control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (approx. 104 mg)
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE: not removed


SCORING SYSTEM: OECD/ Draize
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: Slight redness was seen only 1 hr after application
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: Slight redness was seen only 1 hr after application
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Interpretation of results:
GHS criteria not met
Conclusions:
Following the conditions of the test: No classification as eye irritant according to EU and GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

For the determination of the skin irritation/ corrosion potential, two valid and almost identical studies were available, which were both performed according to OECD TG 404 but did not follow GLP requirements (BASF 1985a, 1985b). Erythema or oedema were not observed in any of the three rabbits after 4 hours of exposure under semiocclusive dressing in both studies.

Eye

For the determination of the eye irritation potential, two valid and almost studies were available, which were both performed according to OECD TG 405 (eyes were left unwashed) but did not follow GLP requirements (BASF AG 1985a, 1985b). Corneal opacity, iritis, redness of the conjunctivae or chemosis were not observed in any of the three rabbits in both studies.

Justification for classification or non-classification

Due to the lack of irritation effects on skin and eye, the substance has not to be classified according to EU and GHS requirements, respectively. However, the risk of mechanical eye damage due to sharp-edged dust particles cannot be excluded.