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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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/corrosion: non-irritating, no guideline followed, non-GLP, 0.5 g test substance, occlusive, rabbit, 1972, K2
Eye irritation: non-irritating, no guideline followed, non-GLP, 0.1 g test substance, rabbit, 1972, K2

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
not specified
Species:
rabbit
Strain:
other: English Silver Strain
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: 2-3 kg
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C):/
- Humidity (%):/
- Air changes (per hr):/
- Photoperiod (hrs dark / hrs light):/

IN-LIFE DATES: From: To:/
Type of coverage:
occlusive
Preparation of test site:
other: shaved and left hand side abraded
Vehicle:
other: 50 % polyethylene glycol suspension
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% solution

VEHICLE
- PEG 400
Duration of treatment / exposure:
24h
Observation period:
72h
Number of animals:
6 (3 per sex)
Details on study design:
TEST SITE
- Area of exposure: back and flanks
- % coverage: /
- Type of wrap if used: A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- no washing

SCORING SYSTEM: Draize system
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is to be considered as non-irritant to the skin of rabbits.
Executive summary:

In the course of the skin irritation study, six English silver Strain rabbits (three per sex) were exposed for 24 hours to 0.5 g of the substance in a 50 % polyethylene glycol suspension. Effects were scored 24 and 72 hours after removal of the occlusive wrap. The test article did not induce any effects on intact or abraded rabbit’s skin.


 

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
"Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: English Silver strain
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: /
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C): /
- Humidity (%): /
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): /

IN-LIFE DATES: From: To: /
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
30 sec until washing, 7 days without washing (observation period)
Observation period (in vivo):
7d
Number of animals or in vitro replicates:
3 per sex
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 10 ml warm water
- Time after start of exposure: after 30 sec

SCORING SYSTEM: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
20
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is to be considered as non irritant to the eye of rabbits.
Executive summary:

A study according to OECD 405 was performed to evaluate the eye irritation potential of the test article. Six English Silver Strain rabbits (three per sex) were exposed to 0.1 g of the test article. The treated eyes were rinsed at three of six animals 30 sec after application. Scoring of irritation effects was performed 1, 2, 3, 4 and 7 days after test article application. The test article did not cause any reaction to washed or unwashed eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation


In the course of the skin irritation study, six (three per sex) English silver Strain rabbits were exposed for 24 hours to 0.5 g of the substance in a 50 % polyethylene glycol suspension. Effects were scored 24 and 72 hours after removal of the occlusive wrap. The test article did not induce any effects on intact or abraded rabbit’s skin.


 


Eye irritation


A study according to OECD 405 was performed to evaluate the eye irritation potential of the test article. Six English Silver Strain rabbits (three per sex) were exposed to 0.1 g of the test article. The treated eyes were rinsed at three of six animals 30 sec after application. Scoring of irritation effects was performed 1, 2, 3, 4 and 7 days after test article application. The test article did not cause any reaction to washed or unwashed 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. In both studies evaluating the skin and eye irritating potential, no effects could be observed after application of the test substance. 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 fifteenth time in Regulation (EC) No. 2020/1182.