Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-968-0 | CAS number: 599-64-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Remarks:
- US EPA GLPs (40 CFR, Part 792) and OECD GLPs
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted prior to the LLNA becoming the preferred method.
Test material
- Reference substance name:
- 4-(α,α-dimethylbenzyl)phenol
- EC Number:
- 209-968-0
- EC Name:
- 4-(α,α-dimethylbenzyl)phenol
- Cas Number:
- 599-64-4
- Molecular formula:
- C15H16O
- IUPAC Name:
- 4-(α,α-dimethylbenzyl)phenol
- Details on test material:
- p-Cumylphenol (PCP, CAS #599-64-4)Purity = 99%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Male and female albino Hartley guinea pigs were received from Elm Hill Breeding Labs, Inc. They were 373.6 to 437.8 g and at least 21 days of age. They were group-housed upon arrival in stainless steel suspended cages. The animals were acclimated for at least 5 days prior to dosing. Water and feed were provided ad libitum. The temperature during the test period was 68 ± 5 degrees F with a relative humidity range of 30 to 70 %. Room lights were on a 12-hour light/dark cycle.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% Ethanol
- Concentration / amount:
- 0.4 g
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone
- Concentration / amount:
- 0.4 g
- No. of animals per dose:
- - Experimental: 10/sex
- Negative Controls: 5/sex
- Positive Controls: 3 males and 2 females
- Preliminary Irritation: 1 male and 2 females - Details on study design:
- Before each application of the test or control substance, the animals were clipped and shaved or depilated on the scapula region in an area of about 3 x 4 cm.
A preliminary irritancy test was conducted, in which it was determined that 0.4 g PCP moistened with 80 % Ethanol was the highest non-irritating concentration.
For the main study, for the induction phase, closed patches for the experimental group were prepared with the PCP moistened with 80 % Ethanol and were applied directly to the skin and covered with a gauze pad of approximately 4 to 6 cm². The patch was kept in place with occlusive bandaging. The patch was removed after 6 hours of exposure and any residual PCP was wiped off with a gauze pad. The test substance was applied once per week for 3 consecutive weeks (Days 0, 7 and 14) on one side of the animal. The positive control substance (dinitrochlorobenzene, DNCB) was applied in the same manner. Naive animals, i.e., untreated during the induction phase, served as a negative control group.
On the day of the challenge, a 4 x 3 cm virgin skin site was shaved on the flanks of the experimental and control animals. The challenge test was performed in the same way as the 6-hour closed patch test of the induction phase. The skin was exposed to PCP for 6 hours. The concentration used at challenge was the highest non-irritating dose determined in the Preliminary Irritation Study. At approximately 21 hours after removal of the challenge dose, the area of the challenge was marked and the whole back shaved. Approximately three hours after shaving, the test site was examined for erythema and oedema. The reaction was graded according to the Magnusson and Kligman Grading Scale for the Evaluation of Challenge Patch Test Reactions. Reading of the skin area was repeated at approximately 48 hours after removal of the challenge dose and the skin reactions were graded.
0 = No reactions
1 = discrete or patchy erythema
2 = moderate and confluent erythema
3 = intense erythema and swelling - Challenge controls:
- - Negative Controls: 5 per sex
- Positive Controls: 3 males and 2 females - Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB)
Results and discussion
- Positive control results:
- Following the challenge application of 0.1 % DNCB to the test animals, 5 of 5 animals developed moderate to intense erythema and oedema within 24 hours. All animals continued to exhibit discrete to moderate erythema and discrete to intense oedema through 48 hours.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 g
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 g
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 g
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 g
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, PCP was not a skin sensitiser.
- Executive summary:
The skin sensitisation potential was investigated in a study performed per OECD Test Guideline 406 and EPA OPPTS 870.2600 under GLP conditions.
Male and female albino Hartley guinea pigs were exposed to the test substance in 80 % Ethanol (induction phase) or Acetone (challenge phase) during a Buehler test.
Under the conditions of this study, PCP was not a skin sensitiser.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
