Registration Dossier
Registration Dossier
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EC number: 931-714-9 | CAS number: 35255-57-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-03-16 to 1998-04-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (1996)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 1998 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Test material
- Reference substance name:
- Reaction mass of 2,2,4-trimethylhexane-1,6-diol and 2,4,4-trimethylhexane-1,6-diol
- EC Number:
- 931-714-9
- Cas Number:
- 35255-57-3
- Molecular formula:
- C9H20O2
- IUPAC Name:
- Reaction mass of 2,2,4-trimethylhexane-1,6-diol and 2,4,4-trimethylhexane-1,6-diol
- Test material form:
- other: liquid
- Details on test material:
- 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediol of Hüls AG
purity 94.6 % (GC-FID area)
batch No. Pt. 15570/3033 of August 1995; sample ID 0637/81 770
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley, Pirbright White, Hsd/Poc:DH (SPF)
- Sex: female
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Age: healthy young adults
- Weight at study initiation: 326 g (mean test); 322 g (mean control)
- Housing: max 5 animals per cage
- Diet (e.g. ad libitum): Sniff G 4 diet, standard guinea pig diet, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
- Controls: 10 animals; treatment: vehicle
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr):15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 6 hour occlusive patch (left side), 0.3 ml undiluted; then removal of residual test material
- Day(s)/duration:
- day 0/7/14 for 6 hours
- Adequacy of induction:
- other: undilluted substance is non irritating
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- two 6 hour occlusive patches (right side), one with 0.3 ml test substance and one with vehicle subsequent removal of residual test material
- Day(s)/duration:
- day 28 for 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- 1st application: Induction undiluted occlusive epicutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Induction undiluted occlusive epicutaneous
ADMINISTRATION/EXPOSURE
- Induction schedule: 3 identical inductions on days 0, 7, and 14: 6 hour occlusive patch (left side), 0.3 ml undiluted; then removal of residual test material assessment 30 hours after each administration
- Challenge schedule: day 28 two 6 hour occlusive patches (right side), one with 0.3 ml test substance and one with vehicle subsequent removal of residual test material assessments 30 and 54 hours after administration
- Concentrations used for challenge: undiluted (100 %)
- Positive control: alpha-hexylcinnamaldehyde (CAS No. 101-86-0) (not concurrent)
Bühler test with 20 test and 10 control animals
Occlusive epicutaneous induction, undiluted
Occlusive epicutaneous challenge with 50 % in corn oil
EXAMINATIONS
- Grading system: Magnusson and Kligman
- Pilot study: determination of slightly and not skin irritating concentrations dermal concentrations: 5; 25; 50; 100 % w/w
3 animals each with 4 different concentrations (0.3 ml each) at different sites
6 hour occlusive patch test followed by removal of residual test material assessment of dermal reactions 30 and 54 hours after administration
- Additional (and identical except for increased body weights) pilot study during week 4; reason: Increase in body weight might cause differences in skin sensitivity - Challenge controls:
- corn oil
- Positive control substance(s):
- not specified
- Remarks:
- alpha-hexylcinnamaldehyde (CAS No. 101-86-0) (not concurrent) Bühler test with 20 test and 10 control animals Occlusive epicutaneous induction, undiluted Occlusive epicutaneous challenge with 50 % in corn oil, checked from 11-24-1997 to 24-12-1997
Results and discussion
- Positive control results:
- Positive control: 10/20 test animals positive 30 hours after challenge, no control animal positive
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- positive control
- Dose level:
- 50 %
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- effects on skin
- Remarks on result:
- other: see above
- Remarks:
- "Positive Control substance(s)
Any other information on results incl. tables
RESULTS OF PILOT STUDY: None of the applied test substance concentrations caused primary skin irritation in any of the two pilot
studies 30 or 54 hours after administration.
RESULTS OF TEST
- Sensitization reaction: No signs of dermal irritation were observed in the application areas of test and control animals 30 and 54 hours after administration.
- Clinical signs: No systemic effects were detected during the observation period.
1st, 2nd, and 3rd induction: No signs of skin irritation were observed in the application areas of test and control animals 30 hours after application.
- Positive control: 10/20 test animals positive 30 hours after challenge, no control animal positive
- Other: The overall mean body weight increase of 250 g (test group) / 249 g (control group) is normal: no treatment related effect.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the Buehler test, the test item showed no evidence of sensitisation.
- Executive summary:
The test substance was tested for skin sensitisation in guinea pigs by the Buehler method.
To determine the potential sensitising effect of this test substance, 20 test animals and 10 control animals as well as an accompanying group of 3 animals were used for the test. 30 and 54 hours after challenge treatment all skin reactions were observed and recorded according to the Magnusson und Kligman grading scale for evaluation of challenge patch test reaction. The test undiluted substance did not cause any skin irritations in a preliminary study. The 100 % test compound was used for the induction period. The concentration used for challenge exposure, the highest non-irritating and nontoxic dose, was identified in the 4th week of the test on the animals of the accompanying group, same age as the animals in the main test. On this basis and based on the results from the induction period, the undiluted test substance was administered for challenge treatment.
During the test, no systemic effects and no impairment of body weight gain due to the test substance were observed in the test and control animals. 30 hours after all three inductions the dermal treatment with the test substance did not cause any skin reactions in the test animals. The control animals treated with the vehicle during the induction periods also showed no signs of skin irritation 30 hours post applicationem (p.a.).
The challenge treatment with the undiluted test compound did not cause any cutaneous reactions on the posterior right flank of any animal in the test and control groups 30 and 54 hours after administration. Neither did the vehicle-laden patch lead to skin reactions in any animal of the test and control groups.
Under the conditions of the Buehler test, the test item showed no evidence of sensitisation.
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