Registration Dossier
Registration Dossier
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EC number: 269-084-6 | CAS number: 68187-29-1
Endpoint summary
Administrative data
Description of key information
Hanzawa, 1991 and 1992
Under the conditions of these studies, the test material was 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:
- key 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:
- 10 female Hartley guinea pigs were assigned to the test group and treated with an intradermal induction of 0.05 mL, 5 % test material solution in distilled water, one week later the area was re-shaved, treated with 10 % SLS solution, and then given an epidermal induction the following day. This exposure lasted for 48 hours. Two weeks after induction animals were shaved again and treated with 5 % test material solution in an occlusive challenge application that was applied for 24 hours. Five animals in the control group were also subjected to the challenge.
The challenge sites were observed 24 and hours following patch removal and the sensitising effect of the test material was evaluated. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate existing data available on the test material using GPMT method.
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test material was dissolved in distilled water for injection to prepare a 5 % solution for both induction and challenge. - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Housing: guinea pigs were kept five per cage in an animal-keeping room.
- Diet: Ad libitum
- Water: Ad libitum tap water
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 3 °C
- Humidity: 55 ± 15 % - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- Intradermal: 5 % / 0.05 mL
Epicutaneous: 5 % solution on cotton lint - Day(s)/duration:
- Intradermal injection on day 1, Epicutaneous application applied on Day 8 for 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 5 % solution was applied to cotton lint
- Day(s)/duration:
- Two weeks after the completion of induction, the occlusive challenge was applied for 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test material group: 10 animals
Control group: 5 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
-The hair of the guinea pigs was shaved with electric hair clippers and an electric shaver on the scapular region.
-0.05 mL of each of the following substances was intradermally administered to sites (1), (2) and (3), by intradermal induction:
Emulsion of Freund's Complete Adjuvant and physiological saline,
Test material
Emulsion of Freund's Complete Adjuvant and the test material.
- The hair of the guinea pigs was shorn in the same area approximately one week following intradermal injection. 10 % SLS petroleum jelly was applied to the area.
- On the following day, the test solution was applied to cotton lint, and the cotton lint was applied to the shorn area and attached for 48 hours using tape (occlusive application: epidermal induction).
B. CHALLENGE EXPOSURE
- The hair of the guinea pigs was shaved lower on the back approximately two weeks following completion of induction. On the following day, the test solution was applied to cotton lint, and the cotton lint was applied to the test site and attached for 24 hours using tape (occlusive application: challenge).
- Skin reactions were examined 24 and 48 hours following patch removal in accordance with the scoring system shown below to evaluate the sensitising effect of the test material:
0: No reaction
1: Mild or scattered erythema
2: Moderate and diffuse erythema
3: Intense erythema and swelling
-The control group was also treated from the challenge stage onwards. - Challenge controls:
- The control animals were untreated in the induction stage but were treated with an occlusive challenge application treatment of the test material alongside the test group animals.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- Under the conditions of this study, the test material was not considered to be a skin sensitiser.
- Executive summary:
The potential of the test material to be a skin sensitiser was investigated in a guinea pig maximisation test.
10 female Hartley guinea pigs were assigned to the test group and treated with an intradermal induction of 0.05 mL, 5 % test material solution in distilled water, one week later the area was re-shaved, treated with 10 % SLS solution, and then given an epidermal induction the following day. This exposure lasted for 48 hours. Two weeks after induction animals were shaved again and treated with 5 % test material solution in an occlusive challenge application that was applied for 24 hours. Five animals in the control group were also subjected to the challenge.
The challenge sites were observed 24 and hours following patch removal and the sensitising effect of the test material was evaluated.
No abnormalities were observed in the test or control group following the challenge. No skin reactions were observed in any animal at 24 or 48 hours.
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:
- 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:
- 10 female Hartley guinea pigs were assigned to the test group and treated with an intradermal induction of 0.05 mL, 5 % test material solution in distilled water, one week later the area was re-shaved, treated with 10 % SLS solution, and then given an epidermal induction the following day. This exposure lasted for 48 hours. Two weeks after induction animals were shaved again and treated with 5 % test material solution in an occlusive challenge application that was applied for 24 hours. Five animals in the control group were also subjected to the challenge.
The challenge sites were observed 24 and hours following patch removal and the sensitising effect of the test material was evaluated. - GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate existing data available on the test material using GPMT method.
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was diluted to 5 % with distilled water for injection. - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Housing: guinea pigs were kept five per cage in an animal-keeping room.
- Diet: Ad libitum
- Water: Ad libitum tap water
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 3 °C
- Humidity: 55 ± 15 % - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- Intradermal: 5 %/ 0.05 mL
Epicutaneous: 5 % solution on cotton lint - Day(s)/duration:
- Intradermal injection on day 1, Epicutaneous application applied on Day 8 for 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 5 % solution was applied to cotton lint
- Day(s)/duration:
- Two weeks after the completion of induction, the occlusive challenge was applied for 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test material group: 10 animals
Control group: 5 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
-Dorsal hair on the scapular region of guinea pigs was shaved with an electric clipper and an electric shaver.
- 0.05 mL each of the following were administered intracutaneously into both right and left sides:
An emulsion of Freund's Complete Adjuvant and saline,
Test material solution and
An emulsion of Freund's Complete Adjuvant and the test material solution.
- Dorsal hair on the same locations was shaved again about one week later after intracutaneous administration, and applied with 10 % SLS.
- On the next day, a piece of lint cloth soaked with the test material solution was attached on the locations, fixed with tape, and then occlusively patched for 48 hours.
B. CHALLENGE EXPOSURE
- About 2 weeks later after the completion of induction, a side region of lower back of the animal body was shaved. On the next day, a piece of lint cloth soaked with the test material solution was attached, fixed with tape to the region, and then occlusively patched for 24 hours.
- Sensitization was evaluated 24 hours and 48 hours after removing the patches with the test substance in accordance with the grades as follows:
0: no visible change
1: slight or discrete erythema
2: moderate erythema
3: intense erythema
-The control group was not treated during the induction stage but was treated identically with the test material group in the challenge phase. - Challenge controls:
- The control animals were untreated in the induction stage but were treated with an occlusive challenge application treatment of the test material alongside the test group animals.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was not considered to be a skin sensitiser.
- Executive summary:
The potential of the test material to be a skin sensitiser was investigated in a guinea pig maximisation test.
10 female Hartley guinea pigs were assigned to the test group and treated with an intradermal induction of 0.05 mL, 5 % test material solution in distilled water, one week later the area was re-shaved treated with 10 % SLS solution and then given an epidermal induction the following day. This exposure lasted for 48 hours. Two weeks after induction animals were shaved again and treated with 5 % test material solution in an occlusive challenge application that was applied for 24 hours. Five animals in the control group were also subjected to the challenge.
The challenge sites were observed 24 and hours following patch removal and the sensitising effect of the test material was evaluated.
No abnormalities were observed in the test or control group following the challenge. No skin reactions were observed in any animal at 24 or 48 hours.
Under the conditions of this study, the test material was not considered to be a skin sensitiser.
Referenceopen allclose all
No abnormality was observed in the test article group or the control group following the challenge.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Hanzawa, 1991 and 1992
The potential of the test material (two different lot numbers) to be a skin sensitiser was investigated in a guinea pig maximisation test. The studies were awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
In each study, 10 female Hartley guinea pigs were assigned to the test group and treated with an intradermal induction of 0.05 mL, 5 % test material solution in distilled water, one week later the area was re-shaved treated with 10 % SLS solution and then given an epidermal induction the following day. This exposure lasted for 48 hours. Two weeks after induction animals were shaved again and treated with 5 % test material solution in an occlusive challenge application that was applied for 24 hours. Five animals in the control group were also subjected to the challenge.
The challenge sites were observed 24 and hours following patch removal and the sensitising effect of the test material was evaluated.
No abnormalities were observed in the test or control group following the challenge. No skin reactions were observed in any animal at 24 or 48 hours.
Under the conditions of these studies, the test material was not considered to be a skin sensitiser.
Read-Across Substance: Anon. (1997)
The skin sensitisation potential of the test material was assessed in a guinea pig maximisation test. The study was awarded a reliability score of 4 in accordance with the criteria set forth by Klimisch et al. (1997).
Ten guinea pigs were treated with 5 % of the test material at sensitisation and a 1.25 % aqueous solution at challenge. Observations were made at 24 and 48 h. Five guinea pigs formed a non-sensitised control group.
Under the conditions of the study no changes were observed in either the sensitised group or non-sensitised control group, and the test material was judged to have no sensitisation potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin sensitisation.
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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