Registration Dossier
Registration Dossier
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EC number: 279-482-1 | CAS number: 80480-24-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: this study was not conducted under GLP as well as no testing guideline was cited. However, the study followed a modification of the Magnusson-Kligman procedure and was therefore comparable to OECD TG 406 (1992).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only subcutanuous application , no top application
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- 5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
- EC Number:
- 279-482-1
- EC Name:
- 5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
- Cas Number:
- 80480-24-6
- Molecular formula:
- C13H26O2
- IUPAC Name:
- 5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
- Test material form:
- other: not reported
- Details on test material:
- - Name of test material (as cited in study report): Troenan
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reporteed
- Weight at study initiation: 598 g
- Housing: groups of 5 in Macrolon cages
- Diet (e.g. ad libitum): Altromin diet 3022
- Water (e.g. ad libitum): local water
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50 %
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: April 1981
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- intradermal: 2 x 3 applications: a) 0.1 mL Freund adjuvans, b) 0.1 mL test substance 5 % in olive oil c) 0.1 mL mixture of Freund adjuvans and 5 % test substance in olive oil (1:1)
epicutaneous: 5 % test substance in olive oil - Day(s)/duration:
- subcutaneous at day 0, epidermal at day 7
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 25 % test substance in 25 % ethanol
- No. of animals per dose:
- control: 20 test organisms in 4 groups a 5 animals (1 animal died in week 1 due to unknown reasons)
test item treatment: 20 test organisms in 4 groups a 5 animals - Details on study design:
- RANGE FINDING TESTS: no
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (subcutaneous at day 0, epidermal at day 7)
- Exposure period: 14 days (subcutaneous) and 7 days (epidermal)
- Test groups: 1
- Control group: 1
- Site:
shoulder region which is cleared of hair so that one of each pair lies on each side of the midline
- Frequency of applications: 1 subcutaneous application, 1 epidermal application
- Duration: 7 and 14 days
- Concentrations:
subcutaneous: 2 x 3 applications: a) 0.1 mL Freund adjuvans, b) 0.1 mL test substance 5 % in olive oil c) 0.1 mL mixture of Freund adjuvans and 5 % test substance in olive oil (1:1)
epidermal: 5 % of test substance in vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Exposure period: 2
- Test groups: 1
- Control group: 1
- Site: lateral part of the body 5 cm x 5 cm
- Concentrations: 25 % test substance in ethanol
- Evaluation: 24 and 48 h after challenge - Challenge controls:
- control group of test organisms
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challange
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- other: challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 19
Any other information on results incl. tables
Body weight of the test organisms in the test item treatment:
weight before the treatment:
mean: 598 g
minimum: 450 g
maximum: 703 g
weight after one week:
mean: 592 g
minimum: 450 g
maximum: 702 g
weight after two weeks:
mean: 606 g
minimum: 455 g
maximum: 708 g
weight after second treatment:
mean: 580 g
minimum: 465 g
maximum: 715 g
weight changes from -12 g to +51 g
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a valid and reliable study, the test substance Troenan was considered not to be a skin sensitizer for guinea pig under the test conditions.
- Executive summary:
The allergenicity test was made on a group of adult female Pirbright White guinea pigs with a mean initial weight of 598 g (test animals) and 565 g (control animals), respectively.
The test group consisted of 20 animals; another 19 animals served as control (1 control animal died in the first week due to unknown reasons). The test substance was prepared by blending a 5 % olive oil preparation of the test substance with Freund's adjuvant at a 1:1 ratio. The induction of sensitisation, the application intervals and the challenge were made according to the modification of the Magnusson-Kligman procedure. Potential skin reactions were read 24 and 48 hours after challenging.
No positive reactions wer obtained from all test animals 24 and 48 hours after challenge. The body weights of the test and control animals showed a normal and parallel development in the course of the test.
According to those results and to maximisation evaluation Troenan can be graded as a non sensitizer for guinea pig.
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