Registration Dossier
Registration Dossier
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EC number: 213-367-9 | CAS number: 939-97-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, sufficient for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
Test material
- Reference substance name:
- 4-tert-butylbenzaldehyde
- EC Number:
- 213-367-9
- EC Name:
- 4-tert-butylbenzaldehyde
- Cas Number:
- 939-97-9
- Molecular formula:
- C11H14O
- IUPAC Name:
- 4-tert-butylbenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): para-tertiary-butylbenzaldehyde
- Analytical purity: no data given
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- induction: 5 %
challenge:
day 21: 3 and 10 %;
day 35: 0.1; 0.3; 1 % (non-irritant concentrations)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- induction: 5 %
challenge:
day 21: 3 and 10 %;
day 35: 0.1; 0.3; 1 % (non-irritant concentrations)
- No. of animals per dose:
- 6
- Details on study design:
- Induction:
0.1 ml of a 5 % test substance emulsion in Freund´s Complete Adjuvant (FCA) was injected intradermally into the neck on days 0, 2, 4, 7 and 9 (control group was treated with FCA only).
Challenge:
Epicutaneously with primary non irritant solutions on day 21 (3 and 10 %) and 35 (0.1, 0.3 and 1 %). These tests were performed by applying 0.025 ml of each test concentration to skin areas measuring 2 cm2. The reactions were read after 24, 48 and 72 hours.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 %. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0 %
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0 %. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 %
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 %. No with. + reactions: 3.0. Total no. in groups: 6.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 6.0.
Applicant's summary and conclusion
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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