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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Not classified for skin irritation or corrosion, or for eye irritation

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:
data from handbook or collection of data
Justification for type of information:
Judged to be scientifically reliable and appropriate for risk assessment by the Expert Panel of dermatologists and scientists at the Cosmetics Ingredient Review, Washington, DC., USA.
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16 CFR 1500.41
Version / remarks:
U.S. Federal Hazardous Substances Act
Principles of method if other than guideline:
Similar to OECD 404 but occlusive exposure to the test material for 24 h. Observation period is 14 days.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino, likely New Zealand white
Details on test animals or test system and environmental conditions:
Mean body weight for one group was 2.29 kg (intact) and the other was 2.81 kg (abraded group)
Type of coverage:
occlusive
Preparation of test site:
other: intact skin and abraded in separate groups
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
2000 mg/kg bw
Duration of treatment / exposure:
24 h
Observation period:
14 d
Number of animals:
10 total, 5 for intact skin exposure, 5 for abraded skin exposure.
Irritation parameter:
erythema score
Basis:
animal: 2/5
Remarks:
at abraded site
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1/2 with erythema persisted to day10; erythema was not related to test material application
Irritation parameter:
other: Desquamation
Basis:
other: 3/5
Time point:
other: day 5-6
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: very slight to slight desquamation
Irritation parameter:
other: desquamation
Remarks:
in Intact skin group
Basis:
other: 2/5
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: very slight to slight desquamation
Irritant / corrosive response data:
No erythema or edema effects were seen at intact skin sites. No edema was observed in any animal during the study.
Of the animals with abraded skin which displayed erythema, the extent was judged to be very mild (score 1 of 4). This resolved in one animal by day 3, but persisted to day 10 in the second. This was judeged by the study director to be unrelated to ATHC administration.

Desquamation, very slight to slight, was observed in five rabbits (three abraded skin, and two intact skin). The onset was day 5 or 6, and was cleared by day 10. At intact sites, desquamation was observed on day 6 or 7 only.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was applied to the skin of rabbits in a very aggressive skin irritation protocol (US FHSA, 16 CFR 1500.41). The findings of no effects in intact skin does not meet the criteria for classification under the CLP regulation. The substance is not classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
Predates Regulation EC No. 863/2016.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Justification for type of information:
Guideline study under GLP, prior to passage of Regulation EC No. 863/2016.
Qualifier:
according to guideline
Guideline:
other: U.S. FHSA, 16 CFR 1500.42
Version / remarks:
Federal Hazardous Substances Act
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
6 animals used
Principles of method if other than guideline:
Similar to OECD 405
GLP compliance:
yes
Specific details on test material used for the study:
Purity 97%
Species:
rabbit
Strain:
other: albino
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
72 h from the beginning of the exposure
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not generally done, but any eyes may be washed with sodium chloride solution U.S.P or equivalent after the 24 h reading
- Time after start of exposure: not before 24 h

SCORING SYSTEM: Draize, et al., 1944, as listed in 16 CFR 1500.42.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
8
Max. score:
110
Irritation parameter:
other: conjunctival redness
Basis:
other: 4/6 animals
Time point:
24 h
Score:
8
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight reddening of the conjunctivae were noted in 4 of 6 rabbits within 6 hours of instillation. In three rabbits, the reddening persisted through 24 h, but had cleared by 48 h. According to the study directors, a positive ocular irritation reaction was not observed in any of the rabbits tested. None of the following changes was observed: chemosis, iritis or corneal opacity or denudation.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance was not irritating in a guideline in vivo study, according to the U.S. FHSA. Classification is not indicated according to Regulation EC No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For evaluation of skin irritation, two studies are available which use a protocol with a harsher exposure scheme than that required by OECD 404 for classification and labelling (Regulation EC No. 1272/2008). The primary differences are an occlusive exposure (rather than semi-occlusive), the abrasion of the skin at half the sites/half the animals, and a duration for 24 h (rather than 4 h). The findings of negligible transient effects in intact skin do not meet the criteria for classification under the CLP regulation.

In an ocular irritation study according to a US protocol similar to an OECD 405, the substance is not an eye irritant. Slight transient conjunctival redness was observed. No chemosis, discharge, iritis or corneal opacity were observed. This is consistent with a study on a structural analogue.

Justification for classification or non-classification

Older in vivo studies reporting negligible transient erythema effects in intact skin under extreme exposure conditions (occlusive, 24 hour, intact and abraded skin) are available for this test substance. Only very slight conjunctival redness was observed in a guideline eye irritation study. These data do not meet the criteria for classification for skin irritation under the Regulation EC No. 1272/2008. The substance is not classified.