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Registration Dossier
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EC number: 248-654-8 | CAS number: 27776-01-8
Endpoint summary
Administrative data
Description of key information
For that endpoint, three studies are available and of good quality. Two were Guinea Pig Maximisation Tests and two were Buehler tests (or similar). These tests were conducted according to OECD 406 guideline or according to similar protocol.
One study was chosen as key study (Kaufmann, 1990). 20 Guinea pigs animals were used as treated group and 20 other animals were used as negative control. The concentrations used for induction were, for intradermal treatment: 5%; and for dermal treatment: 100%. The concentration used in Freund’s Complete Adjuvant (FCA) was 5 %. For challenge, the concentration used was 100 %. No skin reaction was observed for none of the animals. Benzyl toluene was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
In another Guinea Pig Maximisation Tests (Mürmann, 1990), in a Buehler test (Eisele, 1995) and a modified Buehler test (Guillot, 1981), there were no signs of skin sensitisation.
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 mentioned
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study perfromed before the implementation of the REACH regulation
- Species:
- guinea pig
- Strain:
- other: Pirbright white DHPW (SPF)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 301 - 398 g
- Housing: collective housing up to maximum of 5 animals per cage in Makrolon cages type IV
- Diet (e.g. ad libitum): Ssniff G complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 ± 3.5
- Humidity (%): 50 - 85
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not mentioned - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No. of animals per dose:
- test group: 20 animals (10 male, 10 female)
control group: 20 animals (10 male, 10 female) - Details on study design:
- RANGE FINDING TESTS:
Intradermal injection: The test articel was diluted with water and FCA to give a final concentration of 5%. Two animals (1 male, 1 female) were employed, skin reactions being recorded 48 h after treatment.
Dermal application: A closed patch exposure was effected by means of an occlusive bandage. Two animals (1 male, 1 female each) were empoyed for each concentration tested (100%; 50%) and skin reactions were recorded 48 h p.a.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 mL); 2nd exposure: epicutaneous for 48 hours
- Concentration in Freunds Complete Adjuvants (FCA): 5 % test substance in a mixture of FCA and water (1:2)
- Test group: dermal: 100 % test substance (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 0: intradermal treatment, day 7: pretreatment with sodium lauryl sulfate (10% in petrolatum) and day 8: dermal treatment
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance
- Control group: test substance
- Site: left flanks
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene, historical control
- Positive control results:
- The last periodic use of the positive control substance (2,4 dinitrochlorobenzene) resulted in an acceptable level of response in the test animals, not tested in parallel (no further details mentioned).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Benzyltoluene was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
- Executive summary:
The delayed contact hypersensivity of Benzyltoluene was evaluated in Guinea pigs according to OECD N°406 guideline. 20 animals were used as treated group and 20 other animals were used as negative control. The concentrations used for induction were, for intradermal treatment: 5%; and for dermal treatment: 100%. The concentration used in Freund's Complete Adjuvant (FCA) was 5 %. For challenge, the concentration used was 100 %. No skin reaction was observed for none of the animals. Benzyltoluene was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
Reference
RESULTS OF PILOT STUDY:
Intradermal treatment: no specific findings
Dermal application: no skin irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to EU Regulation (EC) N0. 1272/2008 (CLP), benzyltoluene is not classified for skin sensitisation.
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