Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The skin irritating potential of the test substance was evaluated in a GLP-conform study according OECD guideline 404. Three white New Zealand rabbits were exposed to the test item for 4h at 0.5g. Dermal application of the substance caused slight and transient erythema.

 

A structurally related compound was not irritating in the eye.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar 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: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 11 weeks
- Weight at study initiation: not mentioned
- fastened for 16-20h, access to water
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood (RCC Ltd, Fullinsdorf) and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 93/01) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis are archived at RCC Ltd, Itingen. Haysticks (QS no. 125/01) provided by Eberie Nafag AG, CH-9200 Gossau.
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, aof libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES:
Experimental Starting Date 27-DEC-2001
Experimental Completion Date 16-JAN-2002
Delivery of the Animals 27-DEC-2001
Acclimatization 27-DEC-2001 to 01-JAN-2002
Treatment 02-JAN-2002
Observation Throughout 14 days after treatment.
Termination 16-JAN-2002
Study Completion Date 27-FEB-2002
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
The skin reaction was assessed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test item.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flank
- coverage: 100 cm2
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
- Time after start of exposure: 4h

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

ERYTHEMA AND ESCHAR FORMATION
No erythema 0
Very slight erythema 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema)
reading 4

OEDEMA FORMATION
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure).... 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
Slight erythema was observed in all animals 1 hour after treatment. The severity of the erythema increased in all animals to moderate at the 24-hour reading but subsequently cleared within 7 days of treatment.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
The application area was washed after removal of the dressing, however, the test item strongly adhered to the test site and a residue was evident on the skin of all animals throughout the 14 day observation period. A light yellow staining was present at the test site of all animals throughout the 14 day observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of the test substance was investigated by topical semi-occlusive application of approximately 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 1.33, 0.67 and 0.67, respectively and the mean oedema score was 0.00 for all animals. The application to the rabbit skin resulted in mild, eariy-onset and transient signs of irritation. Erythema was observed in all animals during the observation period but diminished to clear within 7 days of treatment. The application area was washed after removal of the dressing but a residue of the test item strongly adhered to the test site and was evident on the skin of all animals throughout the 14 day observation period. A light yellow staining was also present at the test site of all animals throughout the observation period. No corrosive effects were noted on the treated skin of any animal at any measuring interval.

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:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne / France
- Age at study initiation: 16 weeks (male), 15 weeks (females)
- Weight at study initiation: 2741 g (male), 2711 g (female), 2475 g (female)
- Housing: individually
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Fiillinsdorf, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12 hours/12 hours
Controls:
other: The right eye remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.1 g (per animal) of the test article was applied undiluted
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize Scoring System
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: No effects observed
Remarks on result:
other: Slight redness was observed after one hour.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Slight redness was also observed after one hour.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
other: Slight chemosis was observed after one hour.
Interpretation of results:
GHS criteria not met
Conclusions:
No signs of irritation were observed after 72 h observation of the 24 h-treated eye apart from slight irritation within 1-h incubation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Performance and Observation

The primary skin irritation potential of the test substance was investigated by topical semi-occlusive application of approximately 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The application to the rabbit skin resulted in mild, early-onset and transient signs of irritation. Erythema was observed in all animals during the observation period but diminished to clear within 7 days of treatment. The application area was washed after removal of the dressing but a residue of the test item strongly adhered to the test site and was evident on the skin of all animals throughout the 14 day observation period. A light yellow staining was also present at the test site of all animals throughout the observation period. No corrosive effects were noted on the treated skin of any animal at any measuring interval.

 

Data regarding eye irritation is available from a structurally related compoud.

In a GLP conform study the primary irritation potential of the analogue substance was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits according to the OECD guideline 405. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. Slightly reddened conjunctivae was observed in one female and one male animal at the 1-hour observation which persisted in the female until the 24-hour reading. The other female showed slightly reddened conjunctivae only at the 24-hour reading. In both females a slight swelling of the conjuctivae was also seen (at the 1-hour reading only). Yellow remnants in eye or conjunctival sac and around eye and/or on lids by the test article were observed. No corrosion was observed at any of the measuring intervals.

 

Discussion

Dermal application of the test substance induced mild and transient irritation to skin. All symptoms resolved within post observation period and are, therefore, not considered as adverse effects. No ocular irritation potential is expected based on data available with a structural analogue.

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. A GLP-compliant study is available for skin irritation. 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.