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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001/03/13 - 2001/11/29
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
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
There were no deviations from protocol that were considered to have affected the validity of the study. However, the following deviation occurred: Air exchange was maintained at a minimum of 15 air changes per hour, not a minimum of 12-15 air changes per hour as stated in the protocol.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Remarks:
colourless

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Not stated.

- Age at study initiation: 8 to 11 weeks old

- Weight at study initiation: 206 to 237 g

- Housing: Individually housed in cages with wire mesh floors (39x39x20cm)

- Diet: Standard laboratory diet (RM1(E) SQC, ad libitum

- Water: ad libitum

- Acclimation period: minimum of 7 days



ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20.5 to 22°C

- Humidity (%): 35-48%

- Air changes (per hr): minimum of 15

- Photoperiod (hrs dark / hrs light): 12/12 (0600-1800h)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.92 ml/kgbw to achieve a total dosage of approximately 2000 mg/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: The dose level for the study was chosen in compliance with the study guidelines.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3M, 3F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animals were observed on at least two occasions during the first hour following dosing (ca. thirty minutes apart) and thereafter at approximately hourly intervals for the remainder of Day 1 (final observation at 16.00 or 16.20). On subsequent days animals were once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observation. Observations included potential changes in the skin, fur, eyes and mucous membranes, changes in respiratory, circulatory, autonomic, central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed toward the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The body weight of each rat was recorded on days 1 (prior to dosing), 8 and 15. Individual body weights were recorded and body weight changes and group means calculated.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: All animals were subjected to a macroscopic examination, which consisted of examination of the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.
Statistics:
Group mean body weights were calculated using appropriate means (STRAND version 1.0). No other statistical analyses were carried out.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no treatment related deaths during the study.
Clinical signs:
Salivation was seen in all females, immediately after dosing but no clinical signs were seen in males throughout the study. Recovery of the rats as judged by external appearance and behaviour, was complete within approximately one hour of dosing.
Body weight:
Low body weight gain was recorded for one female on Day 15. All other rats were considered to have achieved satisfactory body weight gains during the study.
Gross pathology:
There were no abnormalities observed among animals sacrificed at study termination.
Other findings:
No other findings were reported.

Any other information on results incl. tables

Under the conditions of this study, the acute LD50 of Dow Corning Z-6030 Silane was determined to be greater than 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal oral dose, conducted according to OECD 423 and in compliance with GLP, the test substance was determined to be >2000 mg/kg bw in a reliable study.