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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 24 - August 29, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline test
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
other: solid
Details on test material:
- Batch No. : HT 2025/50
- Stability: 30 years
- Contents of active ingredient: approx. 96%
- Test Article Received: July 5, 1984

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 192 - 215 g
- Fasting period before study: overnight
- Housing: They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding.
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) was provided ad libitum.
- Water (e.g. ad libitum): water was provided ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 55 ±15%
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0l. arachidis Ph. H. VI Siegfried AG
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg hody weight

Duration of exposure:
24 h
Doses:
single dose of 2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on working days, daily, a.m. and p.m. a.m. on weekends for mortaility; on days 1, 7, 14 and at death for body weight
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
From the body weights, the group means and their standard deviations were calculated. Where: feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No mortailty
Clinical signs:
other: Dyspnoea, exophthalmus, ruffled fur and abnormal body positions.
Gross pathology:
No tireatment-related deviations from normal morphology detected.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test condition, it can conclude that LD50 (dermal) of test article to rat is greater than 2000 mg/kg bw.
Executive summary:

The test substance was applied to the skin of rats of both sexes for 24 hrs at a dose of 2000 mg/kg to access the acute toxicity. No mortality was observed at test concentration. No deviation from normal mophology at necropsy. No tireatment-related deviations from normal morphology was detected in any animal. Dyspnoea, exophthalmus, ruffled fur and abnormal body positions were observed, but all rats had recovered within 12 days. Therefore, the LD50 of test substance was estimated to be greater than 2000 mg/kg bw, which indicates that test substance is unclassified in accordance with CLP (Regulaton EC No. 1272/2008).