Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 21, 1995 To December, 1995.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP OECD guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 7-9 weeks (on receipt)
- Weight at study initiation: Males: 225-250 g, Females: 200-225 g
- Fasting period before study: fasted overnight
- Housing: 5 animal/sex/cage in conditioned room ; grill cages 40.5x38.5x18 cm
- Diet: GLP4RF21 (MucedolaS.r.l. Settimo M.se)
- Water : ad libitum
- Acclimation period: at least 5 days before the start of test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2
- Humidity (%): 55+/- 10
- Air changes (per hr): 20
- Photoperiod: 12 hrs dark / 12 hrs light (= 7am - 7 pm)

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no specific indication in report but reference methods cited state 10% of body surface
- Type of wrap if used: No specific indication in report, but reference methods cited state semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 per sexe per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality were observed frequently on the first day after administration and then twice a day/ Body weight was checked twice pre-trial (at randomization and on day 1 to calculate the administration volume) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights.
Statistics:
By the method of the Probit, if possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died.
Clinical signs:
No general or local clinical signs or behavioral alterations were observed in any animal during the observation period.
Body weight:
The body weight gain during the observation period was within the normal limits for animals of this species and strain.
Gross pathology:
The autoptic examination performed on animals killed at the end of the study did not show any change.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, the test article did not cause apparent sign of toxicity by dermal route to rat at the single (limit) dose of 2000 mg/kg bw. Then, the acute dermal LD50 of the test material in rats was determined to be greater than 2000 mg/kg bw. The test article is not classified according to CLP Regulation (EC 1272/2008).
Executive summary:

A study was performed with Sprague-Dawley rats to determine the acute dermal toxicity of the test material. The study was performed according to the OECD guideline 403.The test substance was administered uniformly by gentle inunction onto the cleared dorsal area of the trunk of the animals to groups of 5 male and 5 female fasted rats at the single (limit) dose of 2000 mg/kg bw for 24 hours. The animals were observed frequently on the first day after administration and then twice a day. The bodyweight of the animals were determined at Day 0, 8 and 15. Necropsy was performed on all animals. No animals died. No general or local clinical signs or behavioral alterations were observed in any animal during the observation period. The body weight gain during the observation period was within the normal limits for animals of this species and age. The autoptic examination performed on animals killed at the end of the study did not show any change. Under the test conditions, the acute dermal LD50 of test material in rats was determined to be higher than 2000 mg/kg bw, therefore the substance is not classified according to CLP Regulation (EC 1272/2008).