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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:
weight of evidence
Study period:
from 23 June to 7 July 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
See below
Principles of method if other than guideline:
No guideline stated. Study conforms largely to OECD 402 with minor deviations as stated below.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
EC Number:
915-673-4
Cas Number:
211519-85-6
Molecular formula:
C18H42O6SxSi2
IUPAC Name:
Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Constituent 2
Reference substance name:
Polysulfides
IUPAC Name:
Polysulfides

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH, Borchen, GERMANY
- Age at study initiation: 10-14 wk (males); 10-11 wk (females)
- Weight at study initiation: 224-304 g (males); 161-180 g (females)
- Fasting period before study: 16 h
- Housing: 1/ Macrolon type II cage
- Diet: standard ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h


IN-LIFE DATES: From: 1982-06-23 To: 1982-07-07

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no details given
- % coverage: - No data
- Type of wrap if used: no details given

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no details given

TEST MATERIAL
- Amount(s) applied: 4.64 ml/kg bw (4983 mg/kg bw)
Duration of exposure:
No details of removal of test material. Observation for 28 days following application.
Doses:
4983 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 28 days
- Frequency of observations and weighing: no details given on frequency of clinical observations. Apparently body weights were not recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: no details
Statistics:
None.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 983 mg/kg bw
Based on:
test mat.
Mortality:
No deaths recorded during 28 days observation.
Clinical signs:
No evidence of treatment-related toxicity, however no details were given of the extent of observations.
Body weight:
No reference in this report to body weight measurements.
Gross pathology:
No treatment-related abnormalities reported.
Other findings:
Eschar, recorded in 8/10 animals, finally resolved on day 13. No further details are given.

Any other information on results incl. tables

No tabulated details of findings are given in this report.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A reliable study, conducted largely in a manner similar to the standard guideline but without GLP status, found no mortality or systemic effects in rats treated at 4983 mg/kg bw.

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