Registration Dossier
Registration Dossier
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EC number: 203-005-8 | CAS number: 102-09-0
Endpoint summary
Administrative data
Description of key information
Not sensitising, guinea pig, OECD 406, James (1991)
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Only 10 (instead of 20) animals were used in the treatment group. According to the current guideline, 20 animals are needed to confirm a negative test result.
- Principles of method if other than guideline:
- Buehler, E.V. 1965. Delayed contact hypersensitivity in the Guinea Pig. Arch. Dermat. 91:171-175.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study conducted before LLNA became the standard protocol.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Route:
- other: epicutaneous, occlusive for 6 hours
- Vehicle:
- petrolatum
- Concentration / amount:
- 75 % diphenyl carbonate in petrolatum
- Route:
- other: epicutaneous, occlusive for 6 hours
- Vehicle:
- petrolatum
- Concentration / amount:
- 75 % diphenyl carbonate in petrolatum
- No. of animals per dose:
- 10 per group (test article group, positive compound group, negative control group)
- Details on study design:
- This method utilises an occlusive, topical patch technique applied for six hours at Induction and Challenge. In an initial range-finding study with 12.5 to 75% DCP, suspended in petrolatum USP, all of the tested concentrations were not irritating. Therefore, as maximum non-irritating concentration 75% was used for the main study. In the Main Study (Induction Phase) the test article or positive control article was administered to the respective group of animals by occlusive patch, once per week for three weeks in an attempt to boost the sensitization potential of the animal to the allergen. Two weeks after the final induction exposure, an unused skin site of the animals was challenged with the respective test article or control articles and evaluated for dermal reactions 24 and 48 hours later. Reactions were compared to a negative control group of animals that received the same concentration of test article only at the Challenge Phase. On completion of the Challenge Phase all animals were sacrificed without necropsy.
- Challenge controls:
- see "Details on study design"
- Positive control substance(s):
- yes
- Remarks:
- 0.1% Dinitrochlorobenzene
- Positive control results:
- The positive control Dinitrochlorobenzene (0.1%) exhibited positive reactions in 7 of 10 animals at the 24 hour reading and 6 of 10 animals in the 48 hour reading, indicating that it is a skin sensitiser.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% diphenyl carbonate in petrolatum
- 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: 75% diphenyl carbonate in petrolatum. 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:
- 75% diphenyl carbonate in petrolatum
- 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: 75% diphenyl carbonate in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% diphenyl carbonate in petrolatum
- 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: negative control. Dose level: 75% diphenyl carbonate in petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75% diphenyl carbonate in petrolatum
- 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: negative control. Dose level: 75% diphenyl carbonate in petrolatum. 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% dinitrochlorobenzene
- No. with + reactions:
- 7
- 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% dinitrochlorobenzene. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% dinitrochlorobenzene
- No. with + reactions:
- 6
- 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% dinitrochlorobenzene. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: none.
- Interpretation of results:
- other: not sensitising according to EU criteria
- Conclusions:
- Under the conditions of this study, diphenyl carbonate showed no skin sensitisation potential in a Buehler test.
- Executive summary:
The skin sensitisation potential of diphenyl carbonate was investigated in a Buehler test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. There was a deviation from the current OECD 406 guideline as only 10 (instead of 20) animals were used in the treatment group. According to the current guideline, 20 animals are needed to confirm a negative test result.
During the study female Hartley guinea pigs were dosed with 75 % diphenyl carbonate in petrolatum. This method utilises an occlusive, topical patch technique applied for six hours at Induction and Challenge. In an initial range-finding study with 12.5 to 75 % test material, suspended in petrolatum USP, all of the tested concentrations were not irritating. Therefore, as maximum non-irritating concentration 75 % was used for the main study.
In the Main Study (Induction Phase) the test or positive control material was administered to the respective group of animals by occlusive patch, once per week for three weeks in an attempt to boost the sensitisation potential of the animal to the allergen. Two weeks after the final induction exposure, an unused skin site of the animals was challenged with the respective test or control material and evaluated for dermal reactions 24 and 48 hours later. Reactions were compared to a negative control group of animals that received the same concentration of test material at the Challenge Phase only. On completion of the Challenge Phase all animals were sacrificed without necropsy.
No dermal reactions were observed in any of the animals subjected to the test material (0/10). The positive control, 0.1 % dinitrochlorobenzene, exhibited positive reactions in 7 of 10 animals at the 24 hour reading, indicating that it is a strong sensitiser. In conclusion, the test material when used at a 75% concentration in Petrolatum would be considered a non-sensitiser according to the study design.
Under the conditions of this study, diphenyl carbonate showed no skin sensitisation potential in a Buehler test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of diphenyl carbonate was investigated in a Buehler test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997). There was a deviation from the current OECD 406 guideline as only 10 (instead of 20) animals were used in the treatment group. According to the current guideline, 20 animals are needed to confirm a negative test result.
Female Hartley guinea pigs were dosed with 75 % diphenyl carbonate in petrolatum. This method utilises an occlusive, topical patch technique applied for six hours at Induction and Challenge. In an initial range-finding study with 12.5 to 75 % test material, suspended in petrolatum USP, all of the tested concentrations were not irritating. Therefore, as maximum non-irritating concentration 75 % was used for the main study.
In the Main Study (Induction Phase) the test or positive control material was administered to the respective group of animals by occlusive patch, once per week for three weeks in an attempt to boost the sensitisation potential of the animal to the allergen. Two weeks after the final induction exposure, an unused skin site of the animals was challenged with the respective test or control material and evaluated for dermal reactions 24 and 48 hours later. Reactions were compared to a negative control group of animals that received the same concentration of test material at the Challenge Phase only. On completion of the Challenge Phase all animals were sacrificed without necropsy.
No dermal reactions were observed in any of the animals subjected to the test material (0/10). The positive control, 0.1 % dinitrochlorobenzene, exhibited positive reactions in 7 of 10 animals at the 24 hour reading, indicating that it is a strong sensitiser. In conclusion, the test material when used at a 75% concentration in Petrolatum would be considered a non-sensitiser according to the study design.
Under the conditions of this study, diphenyl carbonate showed no skin sensitisation potential in a Buehler test.
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.
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