Registration Dossier
Registration Dossier
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EC number: 203-786-5 | CAS number: 110-63-4
Skin sensitisation
Administrative data
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute toxicity of 1,4-butanediol in laboratory animals.
- Author:
- Jedrychowski et al.
- Year:
- 1 990
- Bibliographic source:
- Polish Journal of Occupational Medicine 3, (4) 415 - 420
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- not specified
- Principles of method if other than guideline:
- according to Magnusson and Kligman: Allergic contact dermatitis in the guinea pig. Thomas Publ. Springfield, 1970
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The presence of a publication of a guinea pig maximisation test with 1,4-butanediol made the performance of an LLNA test superfluous.
Test material
- Reference substance name:
- Butane-1,4-diol
- EC Number:
- 203-786-5
- EC Name:
- Butane-1,4-diol
- Cas Number:
- 110-63-4
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,4-diol
- Details on test material:
- purity: > 98%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Thirty albino male and female Hartley guinea pigs, body weight 358 ± 36 g, were kept in stainless-steel cages (3 - 4 animals per cage), and had free access to food (LSK, Fodder Plant, Motycz, Poland) and tap water with the addition of vitamin C (400 mg/I).
TEST ANIMALS
- Source: Nofer Institute of Occupational Medicine husbandry
- Age at study initiation: no data
- Weight at study initiation: 358 +/-36 g
- Housing:3-4 animals per stainless steel cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 40-50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- Concentration / amount:
- Induction 10% (intradermal injections), 30% (topical application). The challenge procedure was done with 10 and 30% test substance.
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- Induction 10% (intradermal injections), 30% (topical application). The challenge procedure was done with 10 and 30% test substance.
- No. of animals per dose:
- 20 test groups, 10 control group
- Details on study design:
- The animals were randomly divided into sensitized animals (20) or control group animals (10). In induction procedure, on the basis of preliminary studies, BAD (1,4-butanediol) was applied at a concentration of 10% (intradermal injections) and 30% (topical application). The challenge procedure was done with 10% and 30% BAD (1,4-butanediol).
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 30%
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No allergic contact dermatitis was observed in guinea pigs sensitized with BAD (1,4-butanediol).
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