Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
1983
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

Constituent 1
Chemical structure
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

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.