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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Several studies in rabbits were performed to evaluate irritating or corrosive properties to skin or eyes (OECD guideline 404, 405 and AFDO regulation). Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight conjuctival irritation. All reactions resolved within 2 days or were below the treshold of regualtion. Therefore, the substance is considered to be 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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
information to test substance (purity) not given
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight (kg) at study initiation: 2.22 male and 2.28 female
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10h light period
Type of coverage:
occlusive
Preparation of test site:
other: shaved and right hand site abraded
Vehicle:
other: 50% aqueous solution of polyethylene glycol
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g or 1.5 ml

VEHICLE 50% PEG
- Amount(s) applied (volume or weight with unit): 1.5 ml applied on a 2.5 cm2 gauze pad
- Concentration (if solution): 50%
Duration of treatment / exposure:
24h
Observation period:
after 24 and 72h
Number of animals:
3 per sex
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0.83
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
4
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
4
Remarks on result:
other: abraded and intact skin
Irritant / corrosive response data:
A very slight to slight oedema was seen in 5/6 intact and abraded sites 24 hours after application of the compound. All sites were normal by 72 hours. The primary irritation score was 0.5.
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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no data to test item given (purity)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight (kg) at study initiation: 2.22 male, 2.28 female
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10h light
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
100 mg of the test compound were instilled into the conjunctiual sac of the left eye. The eyelids uere then held closed for 1 second. The right eye serued as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
Observation period (in vivo):
1, 6, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3 per sex
Details on study design:
REMOVAL OF TEST SUBSTANCE
- see above

SCORING SYSTEM: The ocular reactions uere scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
6
Max. score:
110
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
2
Max. score:
110
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 6h
Score:
6.6
Max. score:
110
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 6h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 24h
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
110
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
1.6
Max. score:
110
Reversibility:
fully reversible within: 72h
Remarks on result:
other: unwashed
Irritant / corrosive response data:
A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, washed eyes returning to normal slightly more quickly. All were normal by day 3.
Interpretation of results:
GHS criteria not met
Executive summary:

A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, unwashed eyes returning to normal slightly more quickly. All uere normal by day 3.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Procedure and observations

The test item, 0.5 g dissolved in 50 % PEG, was applied onto shaved or abraded, dorsal rabbits skin (3/sex) and animals were exposed to the substance under occlusive conditions for 24 h (Ciba 1975). Effects on application site were scored 24h and 72h after treatment. Very slight to slight oedema were seen in 5/6 intact and abraded sites 24 hours after application of the compound. All sites were normal by 72h post observation period.

To evaluate the eye irritation potential of the test material, 100 mg of unchanged test material was installed into the conjuctival sac of six rabbits (3/sex). After 30 seconds the eyes of 3/6 rabbits were rinsed with luke warm water. Effects were scored 1, 6, 24, 48 and 72h after treatment. A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, washed eyes returning to normal slightly more quickly. All were normal by day 3.

Discussion

Application of the test substance or the analogue onto skin caused very slight to slight edema which were reversible wihtin post observation period. Application into the conjunctival sac of the eye caused slight conjuctival irritation which was latest reversible within 3 days and which was below the treshold of regulation.

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 irritation under Regulation (EC) No. 1272/2008,as amended for the second time in Directive (EC 286/2011).