Registration Dossier

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:
other: 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:
other: Hazardous Substances, Part 191, Section 11, FDA, Washington, 1965
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chloropropyltriethoxysilane; coded CIPTES; purity 97.9%

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:
The test material was slightly irritating to the rabbit skin following repeated application over 21 days.