Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is pre-GLP and pre-OECD guidelines. The study has been performed according to the method of Noakes, D.N. and Sanderson,, D. M: A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med. 26, pp 59-64 (1968). The result of the experiment is considered reliable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Pre-guideline study according to Noakes, D.N. and Sanderson,, D. M: A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med. 26, pp 59-64 (1968). Two doses suspended in 2% CMC were applied to the shaved backs of each 5 male and 5 female rats. Observation period was 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Remarks:
migrated information: dispersion
Details on test material:
Test material dispersed in 2% Carboxymethylcellulose
- Physical state: solid, dispersed in 2% CMC

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: raised in-house at Ciba-Geigy Ltd. Switzerland, Sisseln
- Weight at study initiation: 180 to 200 grams
- Fasting period before study: no
- Housing: Macrolon cages, individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hours dark / 10 hours light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on dermal exposure:
TEST SITE
- Area of exposure: 60 cm2
- % coverage:
- Type of wrap if used: "dressing fixed with adhesive elastic bandage"

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2150 mg / kg and 3170 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After 4 hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology of organs
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 3 170 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no higher doses tested
Mortality:
none
Clinical signs:
Within 4 hours after treatment the rats in all dosage groups showed syspnoea, curved body position and ruffled fur. No local skin irritation was seen.
The animals recovered from systemic symptoms within 10-12 days.
Body weight:
no data
Gross pathology:
No substance-related gross organ changes were seen

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD0 is > 3170 mg/kg bw in the rat.
Executive summary:

The substance is practically non-toxic. The dermal LD0 is > 3170 mg/kg bw in the rat.