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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 (OECD 404): not irritating

Eye irritation (OECD 405): 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
Study period:
8 - 18 June 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 24 Apr 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 28 Jul 2015
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CEGAV breeding establishment, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individually in cages of standard size
- Diet: SDS/DIETEX STANRAB (P) SQC, distributed daily at fixed times
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: substance was moistened with sterile water
Controls:
other: adjacent areas of the untreated skin of each animal served as controls
Amount / concentration applied:
TEST MATERIAL - Amount applied: 0.5 g (moistened with 0.5 mL sterile water)
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of the right flank region
- Type of wrap if used: The test substance was moistened with vehicle and placed on a gauze square. The gauze square was protected by a pad consisting of a sem-occlusive micro-porous and non-allergenic dressing and held in place with a supple and aerated fastening system consisting of elastic, adhesive, hyperallergenic tape.

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test substance was removed using steril water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
The application of the test substance did not induce colouring of the application site and did not interfere with grading of any skin lesion.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
The study was performed in accordance to OECD TG 404 under GLP conditions and is considered reliable. The test substance was non-irritant.
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:
21 June - 01 July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 Apr 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 09 Oct 2017
Deviations:
yes
Remarks:
No use of analgesics.
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV breeding establishment, Saint Mars d'Egrenne, France
- Age at study initiation: 9 -10 weeks
- Weight at study initiation: 3.1 - 3.2 kg
- Housing: individually in cages of standard size
- Diet: SDS/DIETEX STANRAB (P) SQC, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL - Amount applied: 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Duration of post- treatment incubation (in vitro):
not applicable
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Other effects:
- Other observations: The application of the test substance did not induce colouring of the application site and did not interfere with grading of any eye lesion.

Table 1. Results of eye irritation study.

Rabbit # Time [h] conjunctivae   iris cornea
redness swelling
1 1 0 0 0 0
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0 0 0 0
2 1 1 0 0 0
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0 0 0 0
3 1 1 0 0 0
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0 0 0 0
   
Time [h] conjunctivae   iris cornea
  redness swelling    
average
score		 1 0.67 0 0 0
24 0 0 0 0
48 0 0 0 0
72 0 0 0 0
24+48+72 0 0 0 0
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
The study was performed in accordance to OECD TG 405 under GLP conditions and is considered reliable. In this study, the test substance was not an eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

In a primary dermal irritation study, performed according OECD guideline 404 and in compliance with GLP (M-398621-01-1, 2004), 3 female New Zealand Albino rabbits were dermally exposed to 0.5 g test substance moistened with 0.5 mL sterile water for 4 hours under semiocclusive conditions. Animals were then observed for 3 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean scores for the 24, 48 and 72 h reading for erythema and edema for each animal was 0, respectively. No skin reactions were observed at the 1-hour reading point. In this study, the test substance was not a dermal irritant.

 Eye:

An eye irritation test was performed with three female New Zealand Albino rabbits and performed according to OECD guideline 405 in compliance with GLP (M-398628-01-1, 2004). Eyes were left unwashed after application of 0.1 g test substance and the animals were observed for 72 h. The mean scores for the 24-, 48- and 72-h reading for iritis, cornea opacity and conjunctivae chemosis were 0 at any reading time point. Conjunctivae redness of score 1 was observed in two animals at the 24-h reading time point which was fully reversible after 48 hours. In this study, the test substance was not an eye irritant.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.