Registration Dossier
Registration Dossier
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EC number: 204-337-6 | CAS number: 119-61-9
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:
- other: Test method similar to OECD 406. No GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Benzophenone
- EC Number:
- 204-337-6
- EC Name:
- Benzophenone
- Cas Number:
- 119-61-9
- Molecular formula:
- C13H10O
- IUPAC Name:
- benzophenone
- Details on test material:
- - Name of test material (as cited in study report): Benzophenone
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 400 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Induction: 1 and 10%; Challange: 1 and 5%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- olive oil
- Concentration / amount:
- Induction: 1 and 10%; Challange: 1 and 5%
- No. of animals per dose:
- 20 female guinea pigs
- Details on study design:
- MAIN STUDY
- INDUCTION EXPOSURE
- No. of exposures: 2 dermal injections per test group, one week later 1 dermal aplication
- Exposure period: 48 h (dermal application)
- Test groups: Test substance, test substance + FCA, FCA
- Control group: No data
- Concentrations:
Intradermal: Test substance in olive oil (1%), FCA 50% in distilled water, test substance in FCA (1%)
Dermal: 10% concentration
- CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after dermal induction (day 21)
- Exposure period: 48 hours
- Test groups: Test substance
- Control group: No data
- Site: Same as dermal induction
- Concentrations: 1 and 5%
- Evaluation (hr after challenge): 24 and 48 hours
Note: FCA = Freund's complete adjuvant - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 and 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 and 5% . No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 and 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 and 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Benzophenone was determined to be non-sensitizer to the skin in a Guinea Pig Maximization Test.
- Executive summary:
A Guinea Pig Maximization test was performed with benzophenone in accordance with Magnusson & Kligman method (1970), test method equivalent to OECD 406. 20 Guinea pigs were exposed to the test item during the induction and challenge steps.
Induction consisted of two stages, intradermal injection followed one week later by a 48 h occluded patch application. A total of 6 intradermal injections were administered. They comprised: 2 injections of test substance in olive oil (1%), 2 injections of FCA 50% in distilled water and 2 injections of test substance in FCA (1%). The topical induction concentration were 10%. Fourteen days after topical induction animals were challenged with 1 and 5% test material in olive oil. The treatment sites were examined for evidence of sensitization after patch removal. No sensitization reactions were observed. Therefore, benzophenone was considered to be non-sensitizer to the skin.
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