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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Intracutaneous injection with retest according to "APPRAISAL OF THE SAFETY OF CHEMICALS IN FOODS, DRUGS AND COSMETICS, Assoc. of Food and Drug Officials of the United States 1959"
GLP compliance:
no
Remarks:
study conducted prior to implementation of GLP
Type of study:
intracutaneous test
Justification for non-LLNA method:
A test conducted comparable to generally accepted scientific methods with an insufficient documentation is available, which provides data that indicate no sensitizing potential for the test substance. According to REACH Regulation the performance of new animal studies for the purpose of article 17/18 registrations is not mandatory when existing data are available, which were conducted before REACH Regulation entered into force. For this reason and for reasons of animal welfare no additional LLNA was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
EC Number:
233-487-5
EC Name:
2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
Cas Number:
10196-49-3
Molecular formula:
C6H15NOSi
IUPAC Name:
2,2,4-trimethyl-1,4,2-oxazasilinane

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Remarks:
white
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Kirchborchen, Paderborn
- Weight at study initiation: 300-500 gr
- Diet (e.g. ad libitum): commercial rabbit pellet ration supplemented with greens (kale or lettuce)

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1x 0.05 mL and 9x 0.1 mL of 0.1 % solution
Day(s)/duration:
1 injection per day or 3 per week
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.05 mL from a 0.1 % solution applied 2 weeks after the last injection from induction
Day(s)/duration:
24h
Adequacy of challenge:
not specified
No. of animals per dose:
15 males
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 10-22 days
- Frequency of applications: 1 per day or 3 per week
- Concentrations: 0.1% (1 x 0.05 ml, 8 x 0.1 ml)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after 10th injection
- Concentrations: 0.1% (0.1 ml)
- Evaluation (hr after challenge): 24 hours
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Table 1: Results of the skin sensitisation test

Animal No. Pre-injection Retest
redness score swelling Ø cm redness score swelling Ø cm
927 1 1.5 1 1
929 1 1.1 1 0.5
930 1 0.7 1 0.5
931 1 0.8 1 0.6
932 1 1.0 1 0.4
933 1 0.9 1 0.4
934 1 1.0 1 0.7
935 1 1.1 1 0.5
936 1 1.1 1 0.5
937 1 1.0 1 0.5
938 1 1.0 1 0.5
939 1-2 1.0 1 0.5
940 1 1.0 1 0.5
941 1 1.0 1 0.5
942 1 1.0 1 0.6
Average 1.0 1.0 1.0 0.6

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In this study the test substance is not a dermal sensitiser.
In a dermal sensitization study according to “APPRAISAL OF THE SAFETY OF CHEMICALS IN FOODS, DRUGS AND COSMETICS, Assoc. of Food and Drug Officials of the United States 1959” with the test substance diluted in isotonic saline, 15 white male guinea pigs were tested.
Executive summary:

In a dermal sensitization study according to “APPRAISAL OF THE SAFETY OF CHEMICALS IN FOODS, DRUGS AND COSMETICS, Assoc. of Food and Drug Officials of the United States 1959” with the test substance diluted in isotonic saline, 15 white male guinea pigs were tested.

 

After dermal induction with 0.1 % solution of test substance, very slight to slight redness was observed in only one animal (#939). All other animals showed only very slight redness during induction. The average swelling was 1.0 Ø cm.

Challenge treatment was performed with the same concentration of 0.1 %. Here, all animals showed only very slight redness. The average swelling was 0.6 Ø cm

 

The test substance is not a dermal sensitiser in this study.

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