Carbamic acid, N-[(dimethoxymethylsilyl)methyl]-, methyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Aug - 11 Sep 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate

Cas Number:

23432-65-7

Molecular formula:

C6H15NO4Si

IUPAC Name:

methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 210 - 221 g (male), 198 - 208 g (female)
- Fasting period before study: no
- Housing: animals were barrier maintained (semi-barrier) in Macrolon Cages on Altromin saw fiber bedding
- Diet: Altromin 1324 maintenance diet for rats and mice (totally pathogen-free), ad libitum
- Water: tap water, ad libitum
- Acclimation period: adequate acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: not less than 10% of body surface
- Type of wrap if used: test item was held in contact with the skin with a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner

REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was removed by using water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination was made twice on the day of dosing and once daily thereafter, weighing was performed prior to application and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical examination included changes in the skin/fur, oedema and erythema, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality was observed during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period.

Gross pathology:

Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animal.

Other findings:

No changes of the skin at the application site were observed.

Any other information on results incl. tables

Table 1: Weight gain [g] of the animals in the acute dermal toxicity study.

Animal No.	Sex	Day 0	Day 7	Day 14
1	male	218	249	293
2	male	220	252	298
3	male	210	243	286
4	male	221	246	291
5	male	213	232	260
6	female	202	186	189
7	female	208	217	229
8	female	201	204	211
9	female	205	209	233
10	female	198	200	212

 

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In an acute dermal toxicity study according to OECD guideline 402 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed at the limit dose of 2000 mg/kg bw. Furthermore no skin reactions were observed after the 24-h treatment under occlusive conditions. In conclusion a LD50 >2000 mg/kg bw was derived.