Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexamethyldisiloxane
EC Number:
203-492-7
EC Name:
Hexamethyldisiloxane
Cas Number:
107-46-0
Molecular formula:
C6H18OSi2
IUPAC Name:
hexamethyldisiloxane

Test animals

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

- Source: IFFA CREDO

- Weight at study initiation: 180-200g

- Housing: in individual cages (37.5x17x15 cm)

- Diet: IFFARAT feed, ad libitum

- Water: ad libitum



ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 +/- 1C

- Humidity (%): 50 +/- 10

- Air changes (per hr): 8



IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: shaved dorsal skin

- Type of wrap if used: an aluminium sheet, held in place with adhesive tape


REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed



TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.62 ml/kg



Duration of exposure:
Single application, not rinsed
Doses:
2000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days


Statistics:
No statistical analysis reported in the study report.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the study.
Clinical signs:
other: No skin reactions were noted during the exposure or over the 14 day observation period.
Gross pathology:
Not reported.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal LD50 value of >2000 mg/kg was determined for male and female rats in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.