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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Skin irritation study was performed according to OECD guideline 402 to determine the toxic nature of test chemical. 10 New Zealand White rabbits were dosed at 2000 mg/kg bw for 24hr, 48hrs and 72hrs. The test chemical was dissolved in physiological saline. No edema or erythema was observed after 72hrs. Thus the test chemical was considered to ‘Not Irritating’.

Eye irritation: Eye irritation study was performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) on rabbits. 9 New Zealand White rabbits were used in the study and the test chemical was applied at a concentration of 100 mg/kg bw for 4 hours. conjunctivae score of 1.67 was observed after 48 hrs of study, chemosis score of 0.67 was observed after 48 hrs of study, cornea opacity score of 0.16 was observed after 24 hrs of study and the iris score was 0 throughout the observation period. Changes were fully reversible within 3 days. As the toxic effects of the test chemical were reversible within 3 days, it was considered to be ‘not irritating’ to eyes in nature.

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)
Qualifier:
according to guideline
Guideline:
other: OECD guideline 402
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
2000 mg
Duration of treatment / exposure:
24 h/ 48hs/72hrs
Observation period:
72 hrs
Number of animals:
10
Details on study design:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0d; Max.value at end of observation period:0
Irritation parameter:
erythema score
Time point:
24/48/72 h
Remarks on result:
other: Not available
Irritation parameter:
edema score
Time point:
24/48/72 h
Remarks on result:
other: Not available
Irritant / corrosive response data:
not specified
Other effects:
not specified
Interpretation of results:
other: Not irritating
Conclusions:
Skin irritation study was performed according to OECD guideline 402 to determine the toxic nature of test chemical. 10 New Zealand White rabbits were dosed at 2000 mg/kg bw for 24hr, 48hrs and 72hrs. The test chemical was dissolved in physiological saline. No edema or erythema was observed after 72hrs. Thus the test chemical was considered to ‘Not Irritating’.
Executive summary:

Skin irritation study was performed according to OECD guideline 402 to determine the toxic nature of test chemical. 10 New Zealand White rabbits were dosed at 2000 mg/kg bw for 24hr, 48hrs and 72hrs. The test chemical was dissolved in physiological saline. No edema or erythema was observed after 72hrs. Thus the test chemical was considered to ‘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)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
4 hrs
Observation period (in vivo):
72 hrs
Duration of post- treatment incubation (in vitro):
not specified
Number of animals or in vitro replicates:
9 animals used
Details on study design:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
1.67
Max. score:
1.67
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0.67
Max. score:
0.67
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0.16
Max. score:
0.16
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Conjunctival irritation including blisterine in all but one animal after test article administration
Interpretation of results:
other: Not irritating
Conclusions:
Eye irritation study was performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) on rabbits. 9 New Zealand White rabbits were used in the study and the test chemical was applied at a concentration of 100 mg/kg bw for 4 hours. conjunctivae score of 1.67 was observed after 48 hrs of study, chemosis score of 0.67 was observed after 48 hrs of study, cornea opacity score of 0.16 was observed after 24 hrs of study and the iris score was 0 throughout the observation period. Changes were fully reversible within 3 days. As the toxic effects of the test chemical were reversible within 3 days, it was considered to be ‘not irritating’ to eyes in nature.
Executive summary:

Eye irritation study was performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) on rabbits. 9 New Zealand White rabbits were used in the study and the test chemical was applied at a concentration of 100 mg/kg bw for 4 hours. conjunctivae score of 1.67 was observed after 48 hrs of study, chemosis score of 0.67 was observed after 48 hrs of study, cornea opacity score of 0.16 was observed after 24 hrs of study and the iris score was 0 throughout the observation period. Changes were fully reversible within 3 days. As the toxic effects of the test chemical were reversible within 3 days, it was considered to be ‘not irritating’ to eyes in nature.

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

Additional information

Skin irritation:

1)Skin irritation study was performed according to OECD guideline 402 to determine the toxic nature of test chemical. 10 New Zealand White rabbits were dosed at 2000 mg/kg bw for 24hr, 48hrs and 72hrs. The test chemical was dissolved in physiological saline. No edema or erythema was observed after 72hrs. Thus the test chemical was considered to ‘Not Irritating’.

2) Skin irritation study was performed according to OECD TG 404. One male and two female rabbits were exposed to 0.5 g test substance for 4 h. Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin. Based on these observations and on the referred classification criteria, the test substance is considered to be "not irritating" to rabbit skin

Eye Irritation:

1) Eye irritation study was performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion) on rabbits. 9 New Zealand White rabbits were used in the study and the test chemical was applied at a concentration of 100 mg/kg bw for 4 hours. conjunctivae score of 1.67 was observed after 48 hrs of study, chemosis score of 0.67 was observed after 48 hrs of study, cornea opacity score of 0.16 was observed after 24 hrs of study and the iris score was 0 throughout the observation period. Changes were fully reversible within 3 days. As the toxic effects of the test chemical were reversible within 3 days, it was considered to be ‘not irritating’ to eyes in nature.

2) An eye irritation study was performed with test chemical using 5 albino rabbits. A 100 mg sample of the neat chemical was instilled into the rabbit eyes with no washing. Draize scores were reported from 0 through 7 days of observation. Thus, the test chemical was classified as non irritating to the rabbit eye.

Justification for classification or non-classification

Based on the available data, the test chemical is not irritating to Skin and eyes. The test chemical is considered to be not classified in nature.