Registration Dossier
Registration Dossier
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EC number: 412-440-4 | CAS number: 2725-22-6
Endpoint summary
Administrative data
Description of key information
Skin sensitization study was performed according to OECD Guideline 406 (Skin Sensitization) to determine the sensitizing potential of test chemical. In the induction and challenge test, 10 Hartely albino guinea pigs (5 for each test) were induced 100 % test chemical moistened with acetone, 6 control animals (3 for each test) were also used and induced with 0.5ml acetone.
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation of each challenge concentration: 100 % test material moistened with acetone 0/10
Other observations: At challenge, 4 previously untreated animals were dosed with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group. Thus, the test chemical was considered to be ‘Not Sensitizing’ in nature.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- not specified
- Justification for non-LLNA method:
- according to OECD Guideline 406 (Skin Sensitisation)
- Species:
- guinea pig
- Strain:
- other: Hartely albino
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
- Vehicle:
- other: Acetone
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
Concentration of test material and vehicle used for each challenge:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone) - Vehicle:
- other: Acetone
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone)
Concentration of test material and vehicle used for each challenge:
a) 100 % moistened with acetone
b) 100 % (0.5 ml acetone) - No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 6 - Details on study design:
- not specified
- Challenge controls:
- not specified
- Positive control substance(s):
- not specified
- Positive control results:
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 6.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 6.0.
- Group:
- positive control
- Remarks on result:
- other: Not available
- Interpretation of results:
- other: Not classified
- Conclusions:
- From the above information, it was concluded that the test chemical was not sensitizing to the skin of guinea pigs.
- Executive summary:
Skin sensitization study was performed according to OECD Guideline 406 (Skin Sensitization) to determine the sensitizing potential of test chemical. In the induction and challenge test, 10 Hartely albino guinea pigs (5 for each test) were induced 100 % test chemical moistened with acetone, 6 control animals (3 for each test) were also used and induced with 0.5ml acetone.
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation of each challenge concentration: 100 % test material moistened with acetone 0/10
Other observations: At challenge, 4 previously untreated animals were dosed with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group. Thus, the test chemical was considered to be ‘Not Sensitizing’ in nature.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation of each challenge concentration:
100 % test material moistened with acetone 0/10
Other observations:
At challenge, 4 previously untreated animals were doesd with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Skin sensitization study was performed according to OECD Guideline 406 (Skin Sensitization) to determine the sensitizing potential of test chemical. In the induction and challenge test, 10 Hartely albino guinea pigs (5 for each test) were induced 100 % test chemical moistened with acetone, 6 control animals (3 for each test) were also used and induced with 0.5ml acetone.
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation of each challenge concentration: 100 % test material moistened with acetone 0/10
Other observations: At challenge, 4 previously untreated animals were dosed with 100 % of the test material moistened with acetone. All 4 animals exhibited slight dermal response. Comparison of the incidence and severity indices revealed no meaningful differences between the test and naive control group. Thus, the test chemical was considered to be ‘Not Sensitizing’ in nature.
Justification for classification or non-classification
The test chemical is not sensitizing in nature.
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