(3-chloropropyl)triethoxysilane

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1976-1977

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

Provides basic data but not consistent with standards required for a repeated dose toxicity study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Hazardous Substances, Part 191, Section 11, FDA, Washington, 1965

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloropropyl)triethoxysilane

EC Number:

225-805-6

EC Name:

(3-chloropropyl)triethoxysilane

Cas Number:

5089-70-3

Molecular formula:

C9H21ClO3Si

IUPAC Name:

(3-chloropropyl)triethoxysilane

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on exposure:

A patch-test procedure was used to evaluate the primary irritation characteristics of the test article over a 3-week period. Six male and six female New Zealand white rabbits were used in the test. The test article (0.5 ml) was applied under patches 8 hours/day for 21 days on the sheared intact (6 animals; 3/sex) or abraded (6 animals; 3/sex) back skin of rabbits. The animals were carefully resheared every 3 days.

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

8 hours/day

Frequency of treatment:

21 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0.5
Basis:
other: ml

No. of animals per sex per dose:

6 animals/sex/0.5 ml

Control animals:

no

Examinations

Observations and examinations performed and frequency:

The following parameters were recorded daily: skin reaction (according to the Draize scale), behavior, general condition, food consumption, and body weight development. The primary irritation characteristics of the test article were estimated by averaging the skin irritation scores recorded on days 1, 7, 14 and 21 days.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

effects observed, treatment-related

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Details on results:

Erythema (grade 1) was noted in both the intact and abraded skin by day 4. Erythema (grade 2) was first noted in the abraded skin of one animal on day 6 and the erythema scores for abraded skin were 2 or higher by day 12. Erythema (grade 2) was first noted in the intact skin of one animal on day 8 and the erythema scores for intact skin were 2 or higher by day 13. The maximum mean erythema scores ranged from 2.3 - 2.5 over the study. Edema (grade 1) was not evident in the abraded and intact skin of the animals until days 6 and 7, respectively. Edema (grade 2) developed and persisted in two animals with intact and two animals with abraded skin until the end of the study. The maximum mean edema score was 1.3. Based on a maximum score of 2.2 at the 21-day time point, the results of this study indicate that CIPTES is slightly irritating. There were no signs of systemic toxicity; general condition, food consumption and body weight development were normal.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

In a non assignable dermal repeated dose toxicity study, the test material was found slightly irritating to the rabbit skin following repeated application over 21 days.