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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 IRRITATION:
A study was performed to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. The study design was based on OECD Guidelines No. 404. The test item was classified as a non-irritant to rabbit skin. No corrosive effects were noted.
EYE IRRITATION:
A study was performed to determine the primary eye irritation index and corrosive effects of the test item in the New Zealand White rabbit. The study design was based on OECD Guidelines No. 405. The test item was classified as a non-irritant to rabbit eyes.

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:
March 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study, non-GLP
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Buxted Rabbit Co. Ltd., Great ToteaseFarm, Buxted, Sussex, UK
- Age at study initiation: no data
- Weight at study initiation: 2.2-3.0 kg
- Housing: individually in grid floor cages
- Diet (e.g. ad libitum): Standard Rabbit Diet from B.P. Nutrition U.K. Ltd., Witham, Essex
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ambient temperature
- Humidity (%): ambient humidity
Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g test item
Duration of treatment / exposure:
4 hours
Observation period:
24 and 48 hours after treatment
Number of animals:
6 female rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 hors
Score:
0
Max. score:
0
Irritant / corrosive response data:
The primary irritation index of test article was 0.14 (taking into account the 4 hour-reading with a score of 1 in 1/6 animals). The test article is therefore regarded as mild irritant, not requiring any classification. The structure of the tissue at the contact site was not destroyed within 24 hours of application in any of the 6 animals and the test article is therefore considered non-corrosive, too.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be non-irritating to rabbit skin.
Executive summary:

A study was performed to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. The study design was based on OECD Guidelines No. 404. Six female rabbits were tested and 0.5 ml test substance applied undiluted onto the clipped skin area of the animals. A single 4 -hour application produced a primary irritation index of 0.14. The test item was classified as a non-irritant to rabbit skin. No corrosive effects were noted.

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:
March 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A., (Como), Italy
- Age at study initiation: 9-11 weeks
- Weight at study initiation: ca. 2 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): anti-biotic free pelleted laboratory diet (Altromin MSK, A. Rieper, Bolzano, Italy)
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): Artificial lighting by fluorescent tubes was set to a 24 hour cycle of 12 hours light / 12 hours dark
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 g test item
Duration of treatment / exposure:
see below
Observation period (in vivo):
1, 24, 48 and 72 hours after dosing
Number of animals or in vitro replicates:
3 male rabbits
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No reaction was observed in the treated eyes of any of the three animals at examinations performed approximately I, 24, 48 and 72 hour after dosing.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Th test item was found to be non-irritating to the rabbit eyes.
Executive summary:

A study was performed to determine the primary eye irritation index and corrosive effects of the test item in the New Zealand White rabbit. The study design was based on OECD Guidelines No. 405. Three male rabbits were tested and 0.1 g test substance applied undiluted into the right eye of the animals. No reaction was observed in the treated eyes of any of the three animals at examinations performed approximately 1, 24, 48 and 72 hour after dosing.. The test item was classified as a non-irritant to rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Source: GLP-reports


Justification for selection of skin irritation / corrosion endpoint:
GLP Klimisch 1 study

Justification for selection of eye irritation endpoint:
GLP Klimisch 1 study

Justification for classification or non-classification

Based on the data available the substance is not classified according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).