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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented study according OECD 402 guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
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): sodium vinylsulphonate VSS
- Analytical purity: 25.4 %
- Impurities (identity and concentrations): water 66.9%, isethionic acid 2.85%, sulphate 0.70%, insolubles in methanol 1.22%
- Purity test date: 11-01-1993
- Lot/batch No.: 2B20AA
- Stability under test conditions: stable for the duration of the study
- Storage condition of test material: 4°C in dark
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: 7-10 weeks prior to dosing (day 1)
- Weight at study initiation: 200-243 g
- Housing: individually in metal cages with wire mesh floors in building R14 room 6
- Diet (e.g. ad libitum): standard laboratory rodent diet (Biosure LAD1) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): mean daily relative humidity was 49% R.H.
- Air changes (per hr): 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12, 12 hours artificial light (0700-1900 hours)

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 50 mm x 50 mm
- Type of wrap if used: gauze which was held in place with a non-irritative dressing encircled firmly around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done):at the end of 24h exposure skin was washed with warm (30 to 40 °C) water and blotted dry with absorbent paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw


Duration of exposure:
24 h
Doses:
2 g/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: cages of rats were checked at least twice daily for any mortalities, bodyweights were recorded on day 1, 8 and 15. Individual weekly bodyweight changes were calculated.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: animals were observed soon after dosing and at frequent intervals for the remainder of day 1 (a period of 7 h). On subsequent days animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approx 16.30 h on week days or 11.30 h on Saterdays, Sundays abd public holidays. The nature and severity of the clinical signs and time were recorded at each observation.
Macroscopic examination: all animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths following a single dermal application of sodium vinylsulphonate at 2000 mg/kg bw.
Clinical signs:
There were no signs of systemic reaction to treatment.
Body weight:
Slightly low bodyweight gains were recorded for two females on Day 8 and for two males on Day 15; a small bodyweight loss was recorded for one female on Day 8. All other rats achieved anticipated bodyweight gain throughout the study.
Gross pathology:
No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Conclusions:
The acute lethal dermal dose to rats of sodium vinylsulphonate was found to be greater than 2000 mg/kg bw.