Registration Dossier
Registration Dossier
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EC number: 400-640-4 | CAS number: 198153-89-8
Endpoint summary
Administrative data
Description of key information
Skin: The substance did not induce any effects of skin sensitisation in an in vivo study with guinea pigs (OECD 406, maximisation test).
Respiratory: not available
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:
- 12 Sep - 13 Oct 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
EEC Directive 79/831 - Principles of method if other than guideline:
- The test was carried out according to the maximization test of Magnusson and Kligman (J. invst. Dermatol. 52, 268-276, 1969), recommended in the OECD guidelines 1981 and in the EEC directive 79/831.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study predates availability of the LLNA method.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy, Basel, Switzerland
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: ca. 10 wks
- Weight at study initiation: 309 - 459 g
- Housing: Macrolon Type III cage, individual housing
- Diet (e.g. ad libitum): standard guinea pig pellets, NAFAG No. 84 6, Gossau SG, ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: n/a
- Indication of any skin lesions: healthy
- Sensitivity controlled every six months with p-phenylenediamine
- Acclimatisation: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 60 % rh
- Photoperiod (hrs dark / hrs light): 14 / 10 - Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- and Freud adjuvant
- Concentration / amount:
- 1% / 0.1 mL
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30% / 0.4 g
- Day(s)/duration:
- 48 h occlusive, then 12 days until challenge
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30% / 0.2 g
- Day(s)/duration:
- 48 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Details on study design:
- The concentrations of the test compound for induction and challenge periods were determined on separate animals.
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as .with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- p-phenylenediamine
- Positive control results:
- Not reported. Guinea pigs are tested every 6 months for sensitivity.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- 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:
- 30%
- 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:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not induce any effects of skin sensitisation in an in vivo study with guinea pigs (OECD 406, maximisation test).
Reference
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
Since the substance did not induce any effects of skin sensitisation in an in vivo study with guinea pigs, the classification criteria of Regulation (EC) 1272/2008 do not apply.
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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