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EC number: 205-748-3 | CAS number: 149-87-1
Endpoint summary
Administrative data
Description of key information
Hanzawa, 2008a: Read-across to a substance with a similar structure.
Under the conditions of the study no skin reaction was observed in the exposure group, and thus the test material was determined to be non-sensitizing.
Supporting Study:
Under the conditions of the study, the test material is not considered to be a skin sensitiser.
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:
- supporting study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guineapig maximisation test.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing data already available using a non-LLNA method.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- not specified
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- not specified
- Concentration / amount:
- 2.5 %
- Day(s)/duration:
- Sensitisation evaluated after 24 and 48 hours post patch removal.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 for the treatment group, 5 for the control group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Concentrations: 5 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Concentrations: 2.5 %
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- The control group without induction was treated with the challenge.
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not sensitising in accordance with EU criteria
- Conclusions:
- Under the conditions of the study, the test material is not considered to be a skin sensitiser.
- Executive summary:
The sensitisation potential of the test material was determined in a guinea pig maximisation test.
Ten guinea pigs were treated with the test material at 5 % concentration for the induction phase, five guinea pigs were untreated as the negative control group. All fifteen animals were treated with a dose of 2.5 % concentration of test material for the challenge phase and were observed for sensitisation at 24 and 48 hours after removal of the patch.
No signs of sensitisation were observed in any of the animals in the treatment or control groups and in conclusion under the conditions of this study the test material was not considered to be a skin sensitiser.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 January 1989 to 14 April 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data. The report was redrafted several years after the study period.
- Reason / purpose for cross-reference:
- other: Read-across target
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- See below.
- Principles of method if other than guideline:
- The study does not state whether the female animals are nulliparous and non-pregnant. Grouping was not a random procedure. The study does not justify how the dose level was selected; it should be the highest concentration to cause mild-to-moderate skin irritation.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing data already available using a non-LLNA method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 weeks.
- Weight at study initiation: 310.5 to 366.8 g
- Housing: Groups of 5, in bracket cages made from aluminium.
- Diet: Solid feed for test animals, ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 to 15 cycles per hour.
- Photoperiod (hrs dark / hrs light): 12 hours from 07:00 until 19:00 hours, with an intensity of between 200 and 500 lux. - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Induction exposure: 20 % intradermal induction; 20% epidermal induction
- Challenge exposure: 10 % - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - Induction exposure: 20 % intradermal induction; 20% epidermal induction
- Challenge exposure: 10 % - No. of animals per dose:
- 10 per dose for the test material group and the positive control.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Site and: An area of approximately 6 cm x 4 cm was prepared on the back of the neck of each animal. Injections were administered over an area of approximately 2 cm x 4 cm.
- Preparation: The exposure site was shaved on Days 1 and 6 prior to intradermal and epidermal inductions.
- Intradermal induction: On Day 2, 0.1 mL of the FCA emulsion fluid, 0.1 mL of the test material solution (or positive control substance), and 0.1 mL of the test material/FCA emulsion fluid (or positive control substance/FCA emulsion fluid) were intradermally induced in pairs.
- Epidermal induction: White petrolatum containing 10.0 % SLS was also applied to the skin on Day 6. On Day 7 cotton lint (2 cm x 4 cm) that was coated with 0.5 mL of the test material (or positive control substance) of the specified concentration was applied onto the same site, and fixed in place using tape.
- Duration: The epidermal induction was occlusively dressed for 48 hours.
B. CHALLENGE EXPOSURE
- Site: An area of approximately 5 cm x 10 cm on the right side of the abdomen.
- Preparation: Shaved on Day 26.
- Challenge exposure: On Day 27 cotton lint (2 cm x 2 cm each) that was immersed in 0.2 mL of the test material (or positive control substance) was applied to the shaved site, and fixed in place using tape.
- Exposure period: 24 hours.
- Evaluation (hr after challenge): Observations of the application sites were made 24 hours and 48 hours after removal of the occlusive adhesion, and sensitivity was assessed. - Challenge controls:
- Two challenge controls were performed, one for the test material and one for the positive control.
- No. of animals per dose: 5 animals per dose.
- Concentrations: Test material, 10 %; Positive control, 0.1 %. - Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitrochlorobenzene (DNCB)
- Positive control results:
- Severe erythema and edema were observed 24 hours after challenge exposure, and escharosis was observed 48 hours after challenge exposure, indicating a positive result.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: None.
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the study no skin reactions were observed and it was concluded that the test material has no skin sensitization potential.
- Executive summary:
The potential for the test material to cause skin sensitization was assessed in a Guinea pig maximisation test, performed according to a methodology similar to that specified in the OCED guideline, 406. Ten Guinea pigs were exposed to the test material. The induction exposure was performed at a concentration of 20 % via intradermal injection followed by epicutaneous application and occluded for 48 hours. The challenge exposure was performed by epicutaneous application at a concentration of 10 % and occluded for 24 hours. Dermal reactions were scored at 24 and 48 hours post challenge. Additional observations were made for clinical signs of toxicity and body weight change. A positive control, 2,4-Dinitrochlorobenzene (DNCB), was run concurrently. Challenge controls were run for both the exposure group and the positive control. Under the conditions of the study no skin reaction was observed in the exposure group, and thus the test material was determined to be non-sensitizing.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material.
- Justification for type of information:
- Read-across from a structurally similar substance. Please refer to the RAAF report (section 13) for further information/ justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
Referenceopen allclose all
Observations
- Clinical observations: During the study period, there were no abnormalities in clinical signs observed.
- Body weight: A decrease in body weight was observed in 7/10 of the treated animals, 2/5 animals in the control group 24 hours after removal of the challenge exposure application (Day 29). 24 hours after removal of the challenge exposure application (Day 29) of the positive test substance DNCB, a decrease in body weight was observed in 8/10 of the animals in the study group and 5/5 of the animals in the control group. The cause is not clear, but since a similar phenomenon was observed in the control group as well, it was determined that this decrease in body weight did not result from the test material.
- Challenge exposure: Skin reaction was not observed in 10% challenge exposure of the test material solution.
Table 1: Skin Reaction Results
Test Group |
Animal No. |
Score |
|
24 hours |
48 hours |
||
Sensitization Test Material (20% intradermal induction; 20% epidermal induction; 10% challenge exposure) |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
4 |
0 |
0 |
|
5 |
0 |
0 |
|
6 |
0 |
0 |
|
7 |
0 |
0 |
|
8 |
0 |
0 |
|
9 |
0 |
0 |
|
10 |
0 |
0 |
|
Mean |
0 |
0 |
|
No. with positive reaction |
0/10 |
0/10 |
|
Positive Reaction Rate |
0 |
0 |
|
Challenge Control Test Material (10% challenge exposure) |
11 |
0 |
0 |
12 |
0 |
0 |
|
13 |
0 |
0 |
|
14 |
0 |
0 |
|
15 |
0 |
0 |
|
Mean |
0 |
0 |
|
No. with positive reaction |
0/5 |
0/5 |
|
Positive Reaction Rate |
0 |
0 |
|
Positive Control (DNCB 0.1% intradermal induction, epidermal induction and challenge exposure) |
31 |
3 |
3 |
32 |
3 |
3 |
|
33 |
3 |
3 |
|
34 |
2 |
3 |
|
35 |
3 |
3 |
|
36 |
3 |
3 |
|
37 |
3 |
3 |
|
38 |
3 |
3 |
|
39 |
3 |
3 |
|
40 |
3 |
3 |
|
Mean |
2.9 |
3.0 |
|
No. with positive reaction |
10/10 |
10/10 |
|
Positive Reaction Rate |
100 |
100 |
|
Challenge Control (DNCB 0.1%, challenge exposure) |
41 |
0 |
0 |
42 |
0 |
0 |
|
43 |
0 |
0 |
|
44 |
0 |
0 |
|
45 |
0 |
0 |
|
Mean |
0 |
0 |
|
No. with positive reaction |
0/5 |
0/5 |
|
Positive Reaction Rate |
0 |
0 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Hanzawa, 2008a: Read-across to a substance with a similar structure.
The potential for the test material to cause skin sensitization was assessed in a Guinea pig maximisation test, performed according to a methodology similar to that specified in the OCED guideline, 406. Ten Guinea pigs were exposed to the test material. The induction exposure was performed at a concentration of 20 % via intradermal injection followed by epicutaneous application and occluded for 48 hours. The challenge exposure was performed by epicutaneous application at a concentration of 10 % and occluded for 24 hours. Dermal reactions were scored at 24 and 48 hours post challenge. Additional observations were made for clinical signs of toxicity and body weight change. A positive control, 2,4-Dinitrochlorobenzene (DNCB), was run concurrently. Challenge controls were run for both the exposure group and the positive control. Under the conditions of the study no skin reaction was observed in the exposure group, and thus the test material was determined to be non-sensitizing.
Supporting Study
The sensitisation potential of the test material was determined in a guinea pig maximisation test.
Ten guinea pigs were treated with the test material at 5 % concentration for the induction phase, five guinea pigs were untreated as the negative control group. All fifteen animals were treated with a dose of 2.5 % concentration of test material for the challenge phase and were observed for sensitisation at 24 and 48 hours after removal of the patch.
No signs of sensitisation were observed in any of the animals in the treatment or control groups and in conclusion under the conditions of this study the test material was not considered to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification as a skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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