Amino functional alkoxysilanes

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Switzerland
- Age at study initiation: males 9 weeks, females 12 weeks
- Fasting period before study: not reported
- Housing: During acclimation, in groups of 5/sex in Makrolon type 4 cages. Individually in Makrolon type-3 cages during treatment and observation.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 'Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for htis study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the back
- % coverage: 10
- Type of wrap if used: Semi-occlusive dressing was wrapped around the abdomen, and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Mortality and viability were observed once daily during acclimatization period and 1, 2, 3 and 5 hours after test item administration on test day 1 and twice daily during days 2-15. Each animal was examined for changes in appearance and behaviour once daily during the acclimatization phase. 1, 2, 3 and 5 hours after test item administration on test day 1, and once daily during days 2-15. All abnormalities were recorded. Body weights were recorded on days 1, 8 and 15.

- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Reversible slight to moderate reddening (maculated), scaling, and scabbing were noted at the application in 6, 2 and 3 animals respectively. All dermal reactions subsided by day 10. No other clinical signs were observed during the observation period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study, conducted according to OECD Test Guideline 402 and in compliance with GLP, the concluded LD50 value was >2000 in male and female rats.