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Registration Dossier
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EC number: 232-190-8 | CAS number: 7789-79-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea Pig Maximisation Test is available.
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5% test item in sterile water
Challenge
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5% test item in sterile water
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction: Slight to well defined erythema (scores of 1 and 2) at the sites of intradermal injection following administration of Freund's complete adjuvant (test and control groups), the vehicle mixed with Freund's complete adjuvant (control group) and the test item mixed with Freund's complete adjuvant (test group). A very slight erythema (scores of 1) at the sites treated with the test item in the vehicle was observed. No reaction was observed at the sites treated with the vehicle alone (control group). No reaction observed at sites treated with test item at 50 % concentration and vehicle following 40 hours of topical exposure.
Other observations: Changes in body weight were generally similar in animals from both test and control groups during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to CLP Regulation (EC no. 1272/2008)
- Conclusions:
- The test item was tested according to the GPMT (OECD 406). No animal had a reaction during challenging. The test item is not sensitising.
- Executive summary:
The test item was tested according to the GPMT (OECD 406). Induction phase was 0.5 % intradermal and challenge at 50 % in water. No animal had a reaction during challenging.
The substance is classified as no-sensitizing according to the CLP Regulation (EC no. 1272/2008).
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