Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
read across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Equal numbers of healthy male and female CD rats of Sprague-Dawley origin (Hsd/01a:Sprague-
Dawley(CD)) were obtained from Harlan Olac Ltd., Bicester, Oxon, England.
They were in the weight range of 215 to 256 g and approximately seven to ten weeks of age prior
to dosing (Day 1). All the rats were acclimatised to the experimental environment for a period of six
days prior to the start of the study.
The rats were allocated without conscious bias to cages within the treatment group. They were
housed individually in metal cages with wire mesh floors in Building R14 Room 6.
A standard laboratory rodent diet (Biosure LAD 1) and drinking water were provided ad libitum.
Each batch of diet used for the smdy was analysed for certain nutrients, possible contaminants and
micro-organisms.
Results of routine physical and chemical examination of drinking water at source as conducted,
usually weekly by the supplier are made available to Huntingdon Research Centre Ltd. (as quarterly
summaries).
The mean daily minimum and maximum temperamres of the animal room were 21 °C and 24°C
respecdvely and the mean daily relative humidity value was 52% R.H. Air exchange was maintained
at 10 to 15 air changes per hour and lighting was controlled by means of a time switch to provide
12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by cage number and ear punching. Each cage was identified by a
coloured label displaying the dose level, smdy schedule number, animal mark and the initials of the
Smdy Director and Home Office licensee

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
- treated area was covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk
Duration of exposure:
24 h
Doses:
2 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- duration of observation period following administration: 14d
- frequency of observation : twice a day
- frequency of weighting: at day 1, 8, 15

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality and no signs of toxicity observed
Mortality:
none
Clinical signs:
There were no signs of systemic reaction to treatment
Body weight:
A slightly low bodyweight gain was recorded for one male and one female on Day 8 and in three males on Day 15. All other rats achieved the anticipated bodyweight gains throughout the study
Gross pathology:
No macroscopic abnormalities were observed for animals killed on Day 15.
Other findings:
Sites of application of the test substance showed no irritation or other dermal changes. However, a residual yellow staining was evident in a number of animals during the study clearing in all instances by Day 15.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal dermal dose to rats of test item was found to be greater than 2.0 g/kg bodyweight.
Executive summary:

A group of ten rats (five males and five females) was given a single dermal application of the test substance, at a maximum practical concentration of 71.43% w/v in distilled water, and at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. Sites of application of the test item showed no irritation or other dermal changes. However, a residual yellow staining was evident in a number of animals during the clearing in all instances by Day 15. A slightly low bodyweight gain was recorded for one male and one female on Day 8 and in three males on Day 15. All other rats achieved the anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal dermal dose to rats was found to be greater than 2.0 g/kg bodyweight.