Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
3rd September 1985 to 17th September 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study is conducted by recognised test house, to experimental procedure in compliance with OECD Guideline 402 and Annex V of the 6th Amendment of the EEC Directive of 18 September 1979 - Part B: Methods for the determination of toxicity 4.1.3 Acute Toxicity Dermal. Full data set and rationale provided. GLP compliance not specified, although report is subject to Quality Assurance Procedure.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
and EC 79/831/EEC PArt B, 4.1.3
Deviations:
no
GLP compliance:
not specified
Remarks:
No mention of GLP is made within the report; however the report was subject to Quality Assurance at the laboratory where the testing was conducted. As such, it is assumed that the principles of GLP were followed
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): Bontron E-84
- Substance type: Solid
- Physical state: White Powder
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not specified
- Lot/batch No.: No batch number is specified within the report, but the test substance is deemed equivalent based on history of manufacture and use.
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd, Huntingdon, Cambs, England
- Age at study initiation: approximately 6 to 8 weeks of age
- Weight at study initiation: 200 to 248 g
- Fasting period before study: N/A
- Housing: Housed in groups by sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet (Labsure LAD 1) provided ad libitum. The batch diet used for the study was analysed for certain chemical and microbiological contaminants.
- Water (e.g. ad libitum): . Water provided ad libitum. Results of routine chemical examination of water at source (Grafham Final Water) as conducted quarterly by the Anglian Water Authority are made available at Huntingdon Research Centre.
- Acclimation period: Minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -23 °C
- Humidity (%): 61%
- Air changes (per hr): Approximately 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hour period.

IN-LIFE DATES: From: 3rd September 1985 To: 17th September 1985

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 50% w/v paste with 1% methyl cellulose
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal lumbar region
- % coverage: 10% of total body surgave
- Type of wrap if used: Gauze, held in place with an impermeable dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed in warm (30 - 40 deg C) water and blotting dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): 50% w/v paste with 1% methyl cellulose
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): Methyl cellulose
- Concentration (if solution): 1%
- Lot/batch no. (if required): Not specified
- Purity: Not specified
Duration of exposure:
24 hours.
Doses:
All animals were treated at 2000 mg/kg bodyweight.
No. of animals per sex per dose:
A single dose group of ten rats (five males and five females) were treated as specified.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 15
- Frequency of observations and weighing:
Animals were observed soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation.
The treated areas of skin were examined daily for signs of dermal irritation and assessed according to a recognised arbitrary scoring system for the following parameters:
Erythema and eschar formation.
Oedema formation.
All animals were observed for 14 days after dosing. The following was recorded:
a) The nature, severity and approximate time of onset and duration of each toxic sign.
b) individual bodyweights of rats on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
All animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination, which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded.
Statistics:
As a limit test, the LD50 value was determined as the highest dose concentration.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: 95% CL not determined
Mortality:
There were no mortalities following a single dermal dose of the substance at 2000 mg/kg bodyweight.
Clinical signs:
There were no signs of toxicity or skin reactions at the site of application on any animal.
Body weight:
Bodyweight gains were recorded for the majority of rats on Days 8 and 15.
Gross pathology:
Terminal autopsy findings were normal.
Other findings:
None

Any other information on results incl. tables

The acute lethal dermal dose (LD50) to rats was found to be > 2000 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This substance is not classified as being harmful by dermal exposure.