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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
Study period:
1988-07-26, 1988-09-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Organic
- Physical state: Solid
- Analytical purity: Lab. sample
- Lot/batch No.: Z 1436/37R
- Expiration date of the lot/batch: 1991-06
- Storage condition of test material: Room temperature, in the dark
- Other: Insoluble in water

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain as stated in the report: Tif: RAI f (SPF)
- Source: CIBA-GEIGY Ltd., Animal Production, Stein / Switzerland
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 224 - 259
- Housing: Individually in Macrolon cages type 3, with standardized soft wood bedding (Société Parisienne des Sciures, Pantin)
- Diet: Ad libitum, NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland, Rat chow
- Water: Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): appr. 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
peanut oil
Details on dermal exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 10 %
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg body weight
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 males and 5 females. Six male rats have been used, since a male rat was mistakenly applied in the female group. The treatment was repeated with the missing fifth female.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality, signs and symptoms daily; body weight at start, on day 7, and on day 14
- Necropsy of survivors performed: yes
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Piloerection, abnormal body positions, and dyspnea were seen, being common symptoms in acute dermal tests.
The animals recovered within 7 to 9 days. See Table 1.
Body weight:
Body weight was not affected.
Gross pathology:
No deviations from normal morphology
Other findings:
None

Any other information on results incl. tables

Table 1. Observation of symptoms*

Observations Appl. day Days after application
1 2 3 4 5 6 7 8 9 >9
2000 mg/kg, males
piloerection + + + + + + + + +

hunched posture
+ + + +





ventr.recumbency + +








dyspnea + + + + +





2000 mg/kg, females
piloerection + + + + + + + + +

hunched posture
+ + + +





ventr.recumbency + +








dyspnea
+ + + +





* + = slight; ++ = moderate; +++ = severe

Table 2. Mean body weight and standard deviation

Group
Appl.day Day 7 Day 14
Males 242 ± 3.2 272 ± 7.7 302 ± 16.1
Females 245 ± 13.9 260 ± 18.6 269 ±30.2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity LD50 to rats was determined to be >2000 mg/kg bw under the conditions of the test.
Executive summary:

In this guideline (OECD 402) study conducted to GLP standards, the test material (EC 404-360-3) was determined to be practically nontoxic, with an acute dermal LD50 > 2000 mg/kg bw. The test was conducted on rats (male/female) using a single dose of 2000 mg/kg bw and the test material was applied using a vehicle of peanut oil and held in place using a semiocclusive cover. As no mortalities occured the test material is not classified as acutely toxic (dermal) under CLP regulation 1272/2008.