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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: Chinese standard HJ/T154-2004
GLP compliance:
yes
Specific details on test material used for the study:
Sample lot: 100315
Source: Takemoto
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult, 12 weeks old
- Weight at study initiation: male: 2.4 and 2.6 kg, female: 2.4 and 2.5 kg.
- Housing: Bred in plastic breed box (L35 x W50 x H32 cm), one in a cage, cage changed twice a week.
- Diet (e.g. ad libitum): During the whole period, the animal is free to eat.
- Water (e.g. ad libitum): During the whole period, the animal is free to drink.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): 48 - 58
- Photoperiod (hrs dark / hrs light): simulates natural sunlight 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
72 h
Observation period:
72 h
Number of animals:
4
Details on study design:
Normal New Zealand White Rabbit, fine skin, 12 weeks old, weight 2.4 - 2.6 kg, 4 in number, each bred in a cage.
Fur in the back is shaved off 24 hr before testing, the area is 3 x 3 cm2. 0.5g of the sample is evenly spread out on a 2.5 x 2.5 cm2 2-layer guaze fabric rinsed by distilled water, placed on the left side of the exposed skin, and covered by a cellophane, fixed by a non-irritating adhesive tape and strapping in order to let the sample contact with the skin and prevent animal from licking.
The control group is the right side of the skin. The time for administration is 4 hr. After sample contact, remaining sample is washed away by warm water. After the sample is removed, the treated area is observed for 24, 48, 72 hr.
Skin reaction evaluated according to OECD 404-1 (2004). After the average score is calculated, the skin irritation level is evaluated according to OECD 404-2 (2004).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The highest average score for acute skin irritation test in rabbits for the sample is 0, therefore classified as not irritating.
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: Chinese standard HJ/T154-2004
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot number of test material: manufacturer, 100315
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 weeks old
- Weight at study initiation: male 2.2 & 2.6 kg, female 2.3 & 2.5 kg
- Housing: Bred in plastic breed box (L35 x W50 x H32 cm), one in a cage, cage changed twice a week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 46 - 54
- Photoperiod (hrs dark / hrs light): lighting simulates natural sunlight, 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
4 animals
Details on study design:
Choose 4 rabbits, put 0.1g of the sample on their cornea. After treatment release the eyelids, so they can blink naturally.
Eyes aren't wathed 24 hrs within treatment. Left eye serves as self-control.
Eyes examined 1h, 24hr, 48hr, 72hr after treatment.
Eye irritation is evaluated according to OECD 405 method, and sum up the irritation points of the cornea, iris, and conjunctiva as the final accumulated points of an animal. The sum of the accumulated pointed of all animals divided by the number of animals is the final eye irritation point of the sample.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Interpretation of results:
GHS criteria not met
Conclusions:
Under non-washing conditions, the sample shows a conjunctivae score of 1 in 2 animals after 24 h, and a chemosis score of 1 in one animal after 24h. Both reactions are revesible after 48h. Two other animals showed no reactions. This result belongs to non-irritating.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification