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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:
1986-01-09 to 1986-01-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline conform study, conducted under GLP principles, with very minor deficiencies when compared to contemporary standards: the purity and the stability of the test material were not stated in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1981-05-12
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Rezal 67 solution
IUPAC Name:
Rezal 67 solution
Details on test material:
- Name of test material (as cited in study report): Rezal 67 solution
- Label: Ref.QC751E REZAL 67 SOLUTION
- Physical state: pale straw coloured liquid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately ten to fourteen weeks old
- Weight at study initiation: males: 209 - 253 g; females: 207 - 237 g
- Housing: the animals were housed in polypropylene cages with sawdust bedding; during the 24-hour exposure period the animals were individually caged and afterwards the animals were caged in groups of five per sex.
- Diet (ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.
- Water (ad libitum): mains drinking water
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 22°C
- Relative humidity: 45 - 60%
- Air changes: approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): for the purpose of this study the specific gravity (1.292), as given by the study sponsor, was used to calculate the appropriate dose volumes for the required dose level.
Dose volume: 1.55 mL/kg

TEST SITE
- Area of exposure: on the day of the test the back and flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approximately 6 cm X 12 cm.
- % coverage: the calculated volume of the undiluted test material was applied uniformly to an area of shorn skin approximating to 10% of the total body surface area using a graduated syringe.
- Type of wrap if used: a piece of surgical gauze measuring 7 cm X 4 cm was placed over the treatment area and semi-occluded with a double layer of elastic adhesive bandage (ELASTOPLAST) wrapped around the trunk of the rat. The bandage was tightened sufficiently to prevent the animal wriggling free.

REMOVAL OF TEST SUBSTANCE
- Washing: the bandage was carefully removed and the treated skin and surrounding hair wiped with moist absorbant paper to remove any residual test sample.
- Time after start of exposure: after the 24-hour contact period
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: all animals were observed for overt signs of toxicity and mortality 1 and 4 hours after dosing and subsequently at least once daily for 14 days.
Individual bodyweights were recorded on the day of treatment (day 0) and days 7 and 14.
- Necropsy of survivors performed: yes; all animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
Statistics:
Using the mortality data, an assessment of the acute dermal median lethal dose (LD50) of the test material was made.

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.
Clinical signs:
Hunched posture and pilo-erection were observed in all rats on day one, one hour after removal of the dressings.
Additional signs of toxicity also seen at this time in some animals consisted of lethargy, staining around the eyes and a decreased respiratory rate.
All animals recovered and were normal by day two.
Body weight:
Normal bodyweight gains were recorded during the study period.
Gross pathology:
All animals were subjected to gross necropsy. No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of Rezal 67 solution to the rat was found to be greater than 2000 mg/kg bodyweight.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the dermal route.
According to the EC-Regulation 1272/2008 and its subsequent amendments, the test item is not classified as acute toxic via the dermal route.

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