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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Jun - 11 Jul 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
no purity provided

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
directly 5 animals tested instead of single animals in a sequential manner with two animals used at any selected dose level in the main study
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Clorofene
EC Number:
204-385-8
EC Name:
Clorofene
Cas Number:
120-32-1
Molecular formula:
C13H11ClO
IUPAC Name:
clorofene

Test animals

Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Limited
- Age at study initiation: about 10 weeks
- Weight at study initiation: 258 - 306 g (males), 179 - 210 g (females)
- Housing: 5 animals of the same sex per cage in high density polypropylene cages (56 x 38 x 18 cm) with stainless steel grid floors and top
- Diet: Laboratory Diet No. 1, pelleted (K and K Greeff Chemicals Ltd.), ad libitum (except for the removal of food approximately 18 h before the test substance was administered)
- Water: tap water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C (18 - 25 °C acceptable limits)
- Humidity (%): 55% (40 - 65 % acceptable limits)
- Air changes (per hr): approximately 17
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsum
- Type of wrap if used: The test material was held in contact with the skin with aluminium foil which was kept in place and protected by a bandage of waterproof plaster wrapped twice around the trunk of the body with sufficient tension to ensure the dose remained securely in place and in contact with the skin.

REMOVAL OF TEST SUBSTANCE
- Washing: The dermal test sites were cleaned by wiping with a wet paper towel.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: The dose was applied as a thin layer covering the shaven dorsum moistened with 0.2 mL distilled water.
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at least at three separate inspections during the first hour after administration and twice daily after Day 2. A separate record of responses at the dermal test site was made daily from Day 2. Inspection for decedents was conducted three times daily and two times at weekends. Individual bodyweights were determined on the day before dosing and on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
Body weight gains of the majority of animals were within the normal ranges in males and females during the whole study period.
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
- Other observations: Occluded application of the test substance caused discolouration of the treated skin, loss of elasticity from the second or third day after dosing and complete loss of dermal flexibility from Day 8. Intact skin was revealed by the slough of a dark, hard inflexible layer from the dermal test site which began on Day 10 and was completed by one-half of the animals before termination. At necropsy small areas of encrustation or ulceration associated with incomplete slough of eschar-like material from the treatment site were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified