Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 296-229-0 | CAS number: 92368-90-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-05-10 to 1985-06-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA study was conducted as an in vivo study comparable to OCED 406 was conducted, before the first version of the LLNA (OECD 429) was issued in 2002.
Test material
- Reference substance name:
- 2-benzylheptanol
- EC Number:
- 296-229-0
- EC Name:
- 2-benzylheptanol
- Cas Number:
- 92368-90-6
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2-benzylheptan-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 300-389 g
- Housing: up to 4/cage, solid-floor polypropylene cages (supplied by NKP Limited, Dartford, Kent)
- Diet: ad libitum, Guinea Pig FD1 Diet (supplied by Special Diet Services Limited, Witham, Essex)
- Water: ad libitum, tap water
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Remarks:
- for injection
- Concentration / amount:
- Intradermal Induction: 5 % in arachis oil B.P.
Topical Induction: 100 % - Day(s)/duration:
- 48 h for topical induction
- Adequacy of induction:
- other: maximum non-irritant concentration of the test material
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Topical Challenge: 100 %
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS (called Preliminary Siting test):
- Injection with 0.1 mL of 1 and 5 % test substance with observation after 24, 48 and 72 h and 7 days.
- 2 cm* 2 cm patches with 50 and 100 % concentration were applied to clipped skin of guinea pigs that were injected with adjuvant 1-3 weeks before. Patches were removed after 24 h. After 1, 24 and 48 h the skin was evaluated. The maximum non-irritant concentration of the test material was selected for the main study.
MAIN STUDY
A. INDUCTION EXPOSURE (Injection)
- No. of exposures: 1 (3 injection sides)
- Exposure period: 1 injection and 6 days observation
- Test group: 20 animals received 3 pairs of injections: (1) 0.1mL of Freunds complete adjuvant (Difco Laboratories, Detroit, Michigan USA) (2) 0.1mL of a 5 % concentration of the test material (3) 0.1mL of a 50:50 mixture of a 5 % concentration of the test material emulsified in the adjuvant
- Control group: 10 animals received 3 pairs of injections: (1) 0.1mL of Freunds complete adjuvant (2) 0.1mL of vehicle alone (3) 0.1mL of a 50:50 mixture of vehicle emulsified in Freunds complete adjuvant
- Site: 4 cm x 6 cm in the shoulder region
- Frequency of applications: 1 application
- Duration: single injection
- Concentrations: 5 % and 50:50 mixture of a 5 % concentration of the test material emulsified in the adjuvant
A. INDUCTION EXPOSURE (topical)
- No. of exposures: 1
- Day after intradermal injection: day 7
- Exposure period: 48 h
- Test groups: 100 % test substance on Whatman No 4 Filter paper, fixed with Sleek waterproof adhesive strapping in a cross and 3.5 cm x 25 cm length of Elastoplast elastic adhesive bandage which was wound in a double layer around the torso of the animal
- Control group: similar to test group but only vehicle
- Site: 2 cm x 4 cm in the shoulder region
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test group: on clipped right flank 100 %, on clipped left flank vehicle
- Control group: on clipped right flank 100 %, on clipped left flank vehicle
- Site: 5 cm x 5 cm an both flanks
- Concentrations: 100 %
- after 24 h the patches were removed and challenge sites were cleaned using cotton wool soaked in lukewarm water or ether
- Evaluation: was done 24 h after removal (48 h after application) and after 48 h (72 h)
OTHER:
on day 0 and day 24 body weights were recorded - Challenge controls:
- yes, see above
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- 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:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A guinea pig maximization test was conducted. The challenge with 100 % of the test substance resulted in no reactions and therefore it was conclueded that the test substance was non sensitising.
- Executive summary:
A guinea pig maximization test was conducted. The test group consisted of 20 and the control group of 10 guinea pigs. Intradermal induction was done with 3 injection pairs into different sides. The injections contained 1) Freunds complete adjuvant, 2) 5 % concentration of the test material or vehicle only for the control group and 3) 50:50 mixture of a 5 % concentration of the test material emulsified in the adjuvant or 50:50 mixture of vehicle emulsified in Freunds complete adjuvant for the control animals. The topical induction was done with 100 % test substance or vehicle for the control group. The challenge with 100 % of the test substance resulted in no reactions in any of the 20 guinea pigs both at the 24 h and 48 h observations. The animals of the control group showed to reactions either. Therefore it was concluded that the test substance was non sensitising.
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.
