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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: standardized internal test method similar to OECD TG 404, prior GLP, 2 animals (rabbit), diluted test substance (50%), occlusive treatment for 20h, not irritating 


- Eye: standardized internal test method similar to OECD TG 405, prior GLP, 2 animals (rabbit), 50 mg test substance, single exposure without washing, not irritating

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:
comparable to guideline study with acceptable restrictions
Remarks:
occlusive, 20 h treatment, 2 animals, diluted substance (50%)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive treatment, 20 h treatment duration, 2 animals
Principles of method if other than guideline:
Standardized internal test method (BASF test)
GLP compliance:
no
Remarks:
performed prior to the implementation of GLP
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Gaukler
- Weight at study initiation: female: 3.17 kg, male: 3.68 kg

ENVIRONMENTAL CONDITIONS: not reported
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated site of the same animal
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 50 % aqueous solution
- Amount applied: no data

VEHICLE
- dest. water
Duration of treatment / exposure:
20 h
Observation period:
8 days (24, 48 and 72 h and day 6 and 8 after exposure)
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cotton pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water (possibly containing mild detergent)
- Time after start of exposure: 20 h

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Other effects:
Yellow substance residues after 24 h and 8 days in both animals. Slight scaling was observed in one animal during observation period.
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:
comparable to guideline study with acceptable restrictions
Remarks:
incomplete documentation, 50 mg application amount, number of animals
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
reduced application volume, 72 h scoring not performed, number of animals
GLP compliance:
no
Remarks:
performed prior to the implementation of GLP
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.91 kg (female), 2.51 kg (male)

ENVIRONMENTAL CONDITIONS: not reported
Vehicle:
unchanged (no vehicle)
Controls:
other: talcum (amorph) into the other eye
Amount / concentration applied:
50 mg of test substance (100%)
Duration of treatment / exposure:
Single exposure without washing of the eyes
Observation period (in vivo):
8 days (day 0, 1, 2, 5, 7 and 8)
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE: No

SCORING SYSTEM: Evaluation was carried out according to the Draize scoring system

TOOL USED TO ASSESS SCORE: Fluorescein at the end of the observation period
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In the control eyes slight effects were seen, but these were fully reversible within 48 h
Other effects:
Yellow compound residues
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:


The skin irritation potential of the test item was determined by application of a 50% aqueous solution onto skin of two rabbits (f/m) for 20h under occlusive conditions. Effects were scored 24, 48 and 72h after treatment and observed until day 8. A yellowish staining of the skin at the treatment site was recorded. However, the substance did not cause erythema or edema and is therefore not considered to be irritating to skin.


 


Eye:


To investigate the eye irritation potential of the test material, 50 mg of the compound were installed into one eye each of two rabbits (f/m). The eyes were not rinsed after treatment. The effects were scored 24 and 48h after installation, observation took place until day 8. The substance caused minimal conjunctival effects which were reversible within 48h. Moreover, yellow residues in or surround the eyes of the test animals were observed. Therefore, the test item is not considered to be irritating to 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 is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.