2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane

Skin sensitisation

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

Test material information

Constituent 1

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.