Registration Dossier
Registration Dossier
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EC number: 947-805-1 | CAS number: 213077-23-7
Endpoint summary
Administrative data
Description of key information
In vivo guinea pig maximisation test (OECD 406)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted prior to REACH regulations.
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): TK 12437 (Irgastab CH 302)
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: in house
- Weight at study initiation: 320 to 398 g
- Housing: individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): Standard guinea pig pellets - NAFAG No. 845, Gossau SG; ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- 5% / 0.1 mL
- Day(s)/duration:
- Single injection during Week 1
- Adequacy of induction:
- other: Concentration selected based on solubility of the test article and its local and systemic tolerability in a pretest.
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50% / 0.4 g
- Day(s)/duration:
- Single application during Week 2. Applied for 48 hours
- Adequacy of induction:
- other: Concentration selected based on primary Irritation potential
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 10% / 0.2 g
- Day(s)/duration:
- Single application during Week 5. Applied for 24 hours
- No. of animals per dose:
- Test group: 10 males and 10 females
Control group; 5 males and 5 females - Details on study design:
- see above
- Challenge controls:
- A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- no
- Remarks:
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In a guideline (OECD 406) in vivo GMPT study, Irgastab CH 302 was a skin sensitizer in albino guinea pigs. 85% of the test animals were sensitized at an induction concentration of 5%.
Reference
see attached summary table
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
85% of the test animals were sensitized at an induction concentration of 5%.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, Irgastab CH 302 is classified as a Category 1B skin sensitizer according to Regulation (EC) No 1272/2008.
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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