Registration Dossier
Registration Dossier
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EC number: 231-403-1 | CAS number: 7534-94-3
Endpoint summary
Administrative data
Description of key information
Isobornyl methacrylate was demonstrated to be not sensitising in a fully valid GLP guideline study according to 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:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 406, GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12th May 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This in vivo test was already available before reliable in vitro test methods for this substance group were avaiable.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre d' elevage Lebeau, F-78950 Gambais, France
- Weight at study initiation: males: 443±35g; females: 424 ±18g
- Housing: individual polycarbonate cages, 48 x 27 x 20 cm
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3°C
- Humidity (%): 50 ±20 %
- Air changes (per hr): the air was non-recycled and filtered
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs - Route:
- intradermal
- Vehicle:
- other: paraffin oil
- Concentration / amount:
- 1st Induction: 50% intracutaneous
2nd Induction: undiluted occlusive epictaneous
3rd Challenge: undiluted occlusive epictaneous - Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin oil
- Concentration / amount:
- 1st Induction: 50% intracutaneous
2nd Induction: undiluted occlusive epictaneous
3rd Challenge: undiluted occlusive epictaneous - No. of animals per dose:
- Total number of animals: 30
Control group: 10 (5 m and 5 f)
Treated group: 20 (10 m and 10 f) - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
One day 1, 6 intradermal injections (0.1 ml) were made per animal
Controls: Freuds complete adjuvant (FCA) (50 % in aqueous NaCl 0.9 %)); Vehicle; FCA + Vehicle + 50 % aqueous NaCl (0.9 %)
On day 7, 0.5 % sodiumlauryl sulfate in vaseline (10%) was applied dermally to provoke irritation
On day 8, 0.5 ml of the undiluted isobornyl methacrylate was applied dermally to the 6 injection areas
B. CHALLENGE EXPOSURE
After day 22, 0.5 ml of the undiluted test substance (maximum non-irritant concentration) was applied and kept occluded
Scoring was performed after 24hrs and 48 hrs. - Positive control substance(s):
- yes
- Remarks:
- Dinitro-2,4-chlorobenzene
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- yes
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 %. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: yes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of a fully valid Guinea pig maximisation test (OECD 406, GLP), Isobornyl methacrylate is not considered to be a skin sensitizer.
EU-GHS classification: not sensitizing - Executive summary:
Isobornyl methacrylate was tested for it's sensitising potential in Guinea pigs in an OECD 406 GLP study. In the test group, 10 male and 10 female animals were treated via intradermal injection with 0.1 ml of isobornyl methacrylate (50 % in paraffin oil) in presence of Freuds complete adjuvant. At day 8, 0.5 ml of the undiluted test substance was applied cutaneously to the injection sites for 48 hours (occlusive dressing). After a period of 12 days without treatment, a 24 hr-challenge occlusive cutaneous application of 0.5 ml of the vehicle (left flank) and 0.5 ml of the undiluted isobornyl methacrylate was performed. The cutaneous reactions were scored 24 hrs and 48 hrs after removal of the dressing.
No cutaneous reactions were recorded in all test animals.
The sensitivity of the test animals was confirmed by use of 2,4-Dinitrobenzene (0.1 % and 0.5 %). The sensitisation response was 100 %.
Based on the results of this study, Isobornyl methacrylate is not considered to be a skin sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the results of a fully valid Guinea Pig Maximisation Test according to OECD 406 and GLP, Isobornyl methacrylate is not considered to be a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Isobornyl methacrylate was demonstrated to be not sensitising in a fully valid GLP guideline study according to OECD 406.
According to the criteria as of directive 1272/2008/EC, no classification is warranted.
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