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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.09.1998 to 25.02.2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dow Corning Z-6020 Silane
- Substance type: Alkoxy silane
- Physical state: Liquid
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: At least 12 weeks
- Weight at study initiation: 2494-2828 kg
- Fasting period before study: No
- Housing: Individually in suspended metal cages with perforated floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-65
- Air changes (per hr): 15-19
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24.09.1998 To: 08.10.1998

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: lumbar region
- % coverage: approximately 10%
- Type of wrap if used: porous (< 8 ply) gauze held in place with a non irritating dressing, and further covered by a waterproof dressing

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):1.982 mL/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rabbits were observed twice daily for mortality and morbidity. The bodyweight of each animal was recorded on Days 1 (prior to dosing), 8 and 15. Animals were observed immediately after dosing and at approximately hourly intervals for the remainder of Day 1. On subsequent days animals were observed twice.
- Necropsy of survivors performed: yes
- Other examinations performed: Dermal responses were examined on Day 2 to 15. Skin reactions were scored according to the Draize scoring system. A gross macroscopic examination of each animal was conducted.
Statistics:
Mean body weights were calculated. No other statistical analyses were conducted.

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.
Clinical signs:
There were no treatment-related clinical signs of toxicity, except fecal disturbance in one female rabbit.
Body weight:
Slight weight loss was recorded for two females on Day 8, with more notable weight loss in a further female on Day 15, but these findings were not considered to be of any toxicological significance.
Gross pathology:
No abnormal findings.
Other findings:
Persistent slight to moderate irritation (erythema with or without oedema up to Grade 3) was evident in all rabbits following removal of the dressings and over the following days. These reactions had notably ameliorated by the second week of the study with resolution in all but three animals complete by Day 15. In the remaining rabbits slight erythema (Grade 1) was still evident at study termination. Also notable in all rabbits during the first days following treatment was a very dry texture to the skin over the treatment site, desquamation of the skin on the treatment site (all rabbits and present in six rabbits at study termination) and in one rabbit localised necrosis/blanching evident throughout the observation period.

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 conducted to EPA OPPTS 870.1200 (Acute Dermal Toxicity) and to GLP (reliability score 1) the LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine was at least 2000 mg/kg bw in rabbits. No deaths occurred at this dose. There were no clinical signs, macroscopic findings, or significant effects on bodyweight. The only findings were irritation at the application site.