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Registration Dossier
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EC number: 273-453-7 | CAS number: 68966-86-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28th April 1994 to the 27th October 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study was conducted according to OECD 406 and GLP, however, no information was provided on the purity of the test material.
- Justification for type of information:
- The REACH information requirements were revised in 2016 to endorse a battery of in vitro assays for skin sensitisation. Whilst Annex VII does not require in vivo testing for skin sensitisation, all existing available information should be evaluated, including any available animal data, in accordance with Annex VI.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Adopted 17 July, 1992
- Deviations:
- yes
- Remarks:
- no SDS pretreatment
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Maximisation Test (GPMT) (EU B.6/OECD TG 406) is considered to provide sufficient information for hazard identification.There are globally harmonised (GHS) criteria to predict skin sensitisation potency based on the GPMT. The reliable and GLP compliant in vivo GPMT was considered sufficient to fulfil the endpoint.
Test material
- Reference substance name:
- Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate
- EC Number:
- 273-453-7
- EC Name:
- Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate
- Cas Number:
- 68966-86-9
- Molecular formula:
- C14H22O2
- IUPAC Name:
- Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species: Young albino guinea pigs
- Source: Commerical supplier
- Examination: without signs of morbidity, females are nulliparous and non-pregnant
- Housing: Housed individually in Macrolon cages (area 780cm2)
- Acclimatisation: Animals were acclimated to the test conditions for 5 days prior to administration
- Preparation: A 4 x 6 cm2 area of the dorsum was clipped with an electric clipper.
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12:12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- Mahagonat 30% in DPG diluted with sesame oil in the ratio of 1:7. The volume of each injection was 0.1 ml.
- Day(s)/duration:
- Day 0 - 7
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- Mahagonat 30% in DPG diluted with sesame oil in the ratio of 1:7. The volume of each injection was 0.1 ml.
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- other: 30% Test item in DPG diluted with sesame oil (1:3)
- No. of animals per dose:
- Group I (test substance) consisted of 10 animals, while Group II (control) included 5 animals.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE (Day 0)
- No. of exposures: Three intradermal injections were made on each side of the dorsum
TEST ITEM GROUP (GROUP I) INJECTIONS
- 0.1 mL volume of Freunds Complete Adjuvant (FCA) diluted with aqua ad iniectabilia (1:1 ratio)
- 0.1 mL volume of test item 30% in DPG diluted with sesame oil (1:7 ratio)
- 0.1 mL volume of test item 30% in DPG emulsified in FCA in the ratio of 1:3.5 and further diluted with aqua ad iniectabilia (ratio 9:7). The resulting mixture contained 12.5% test item 30%.
CONTROL GROUP (GROUP II) INJECTIONS
- 0.1 mL volume of Freunds Complete Adjuvant (FCA) diluted with aqua ad iniectabilia (1:1 ratio)
- 0.1 mL volume of sesame oil
- 0.1 mL volume of sesame oil emulsified in FCA in the ratio of 2:1 and further diluted with aqua ad iniectabilia (ratio 3:1). The resulting mixture contained 50% sesame oil
B. CAUSING OF A LOCAL IRRITATION (Day 6)
- Preparation: The fur of all guinea pigs was clipped in the dorsal test area and 24-hours prior to topical induction, the test area was applied with a 10% sodium lauryl sulphate mixture in Vaseline (0.5 ml) to create a local dermal irritation
C. DERMAL INDUCTION (Day 7)
- Dose: Filter paper (2 x 4 cm2) loaded with 0.5 ml undiluted Mahagonat 30% in DPG was applied to the dorsum via occlusive dressing
- Exposure period: 48-hours
- Site: Dorsum
D. CHALLENGE EXPOSURE (Day 21)
- No. of exposures: Single exposure
- Day(s) of challenge: 21-day
- Exposure period: 24-hours
- Site: Right flank
- Concentrations: Mahagonat 30% in DPG in a sesame oil vehicle (1:3 ratio)
- Evaluation (hr after challenge): 24 and 48 hours after removal of challenge exposure - Challenge controls:
- Group I (test substance)
Group II (control) - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no allergic reactions noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no allergic reactions noted .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no allergic reactions noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no allergic reactions noted.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no allergic reactions noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no allergic reactions noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no allergic reactions noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no allergic reactions noted .
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Guinea Pig Maximisation Test (GPMT) (EU B.6/OECD TG 406) is considered to provide sufficient information for hazard identification. Conducted according to OECD TG 406, the reliable and GLP compliant in vivo GPMT was considered sufficient to fulfil the sensitisation endpoint for REACH Annex VII. Induction and challenge with the test item (30% in DPG) did not induce mortality, toxicity, body weight changes or alter behaviour of the albino guinea pigs tested (n=10). It can be concluded that under the conditions of the study, the test item does not present skin sensitising potential.
- Executive summary:
The Guinea Pig Maximisation Test (GPMT) (EU B.6/OECD TG 406) is considered to provide sufficient information for hazard identification. The study was chronologically subdivided into the acclimatisation period (day -5 to -1), the induction phase (day 0 to 7) with an intradermal administration of the test substance on day 0 and a dermal one on day 7, followed by a phase free from treatment (day 8 to 19) during which a hypersensitive state is developed in both phases. The dermal challenge was on day 21.
Under the test conditions, no allergic reactions of toxicological signs were observed, following administration of the test item (Group I) or the vehicle (Group II). During the experiment the body weight of all animals had a normal physiological growth. It can be concluded that under the conditions of the study, the test item does not present skin sensitising potential.
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