Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted to recognised international test guidelines. For read-across justification see Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (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:
- Name of test material : CP12
- Physical state: Liquid
- Lot/batch No.: 0012
- Expiration date of the lot/batch: 2015-08-01
- Storage condition of test material: Room temperature

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: 8 - 10 weeks old
- Weight at study initiation: 208 - 306 g
- Housing: Polysulphone solid bottomed cages measuring 42 .5 x 26.6 x 18 cm
- N° of animal/cage: Group caged (during acclimatisation period); Individually caged (study)
- Diet: 4 RF 18 (Mucedola Srl), available ad libitum
- Water :ad libitum
- Acclimation period:at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°c +/- 2°c
- Humidity (%):55% +/- 15%
- Air changes: 15 to 25 air changes per hour
- Photoperiod: Artificial (fluorescent tubes) , daily light/dark cycle of 12/12 hours

IN-LIFE DATES: From: 2012-09-10 To: 2012-09-25

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 10% of body surface
- Type of wrap if used: synthetic film

REMOVAL OF TEST SUBSTANCE
- Washing : After exposure , the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure:24 hours

TEST MATERIAL
- Amount(s) applied : Aliquots were weighed accordingly to the body weight of each animal measured prior dosing
- Constant volume or concentration used: yes
- Frequency of treatment: once only , on the day of dosing
- Treatment area preparation: on the day before dosing

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - 1,2 and 4 hours after first dosing and daily thereafter for 14 days. Weighing - Days -1, 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None during 14 day post-exposure observation period
Clinical signs:
No signs of systemic toxicity observed. Signs of local irritation at treatment site.
Body weight:
No abnormal changes considered to be of significance
Gross pathology:
No abnormal changes considered to be of significance
Other findings:
None

Any other information on results incl. tables

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute toxicity of the substance was investigated following dermal administration of a single dose to the rat at 2000 mg/kg. No mortality occurred following dosing and no signs of systemic toxicity were observed. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
Executive summary:

The acute toxicity of the substance has been investigated following dermal administration of a single dose to the rat at 2000 mg/kg. utilising OECD/EU test methods. No mortality occurred following dosing and no signs of systemic toxicity were observed. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.