Registration Dossier
Registration Dossier
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EC number: 202-443-7 | CAS number: 95-71-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guinea Pig induction method, company protocol
- GLP compliance:
- no
- Type of study:
- skin painting test
Test material
- Reference substance name:
- 2,3,5-trimethylhydroquinone
- EC Number:
- 211-838-3
- EC Name:
- 2,3,5-trimethylhydroquinone
- Cas Number:
- 700-13-0
- IUPAC Name:
- 2,3,5-trimethylbenzene-1,4-diol
- Details on test material:
- - Name of test material (as cited in study report): 2,3,5-trimethylhydroquinone
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 441.2 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- Induction: 20% (2 applications); 50% (8 applications)
Challenge: 5%,
Rechallenge: 20%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- Induction: 20% (2 applications); 50% (8 applications)
Challenge: 5%,
Rechallenge: 20%
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 applications
- Test groups: 10 animals
- Control group: 3 animals
- Site: ca. 25 cm2 clipped area of flank
- Frequency of applications: paintings were done three times in a row, for 5 days per week (together ten times in two weeks)
- Concentrations: 20% (2 applications), 50% (8 applications)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: first challenge 16 days after induction; second challenge 16 days after first challenge
- Test groups: 10 animals
- Control group: 3 animals
- Site: shaved right flank
- Concentrations: 5% (challenge), 20% (rechallenge)
- Evaluation (hr after challenge): 12 h - Challenge controls:
- Not treated during induction period
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 12.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 12
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 12.0. Group: test group. Dose level: 20%. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 12.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 3.0.
- Reading:
- rechallenge
- Hours after challenge:
- 12
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 12.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Any other information on results incl. tables
The test substance was judged to be slightly sensitizing by the authors.
1) Induction:
Repeated application of the test substance at 20% or 50% in acetone produced hemorrhagic encrustations in 10/10 animals of the test group. These symptoms were reversible within the 16-day rest period.
2) Challenge / rechallenge:
Single application of the 5% solution in acetone to the previously untreated site did not produce any skin response in the animals of the test group. In contrast, application of the 20% solution at 16 days later produced a slight erythema in 7/10 test animals. Control animals did not show any skin response after treatment with either 5% or 20%.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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