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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1992-12-02 to 1992-12-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was carried out according to OECD guideline 402.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Exposure period was 24 hours as opposed to the guideline recommended 4 hours
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SX30
- Substance type: Paraffin Wax
- Physical state: white solid
- Analytical purity: Not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Radiochemical purity (if radiolabelling): not reported
- Specific activity (if radiolabelling): not reported
- Locations of the label (if radiolabelling): not reported
- Expiration date of radiochemical substance (if radiolabelling): not reported
- Stability under test conditions: not reported
- Storage condition of test material: at room temperature in darkness

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd, Bicester, Oxon, UK
- Age at study initiation: six to seven weeks old
- Weight at study initiation: 166-178 grams (males) 144-155 grams (females)
- Fasting period before study: no
- Housing: individually in suspended, polypropylene and stainless steel, grid floored cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24 degrees
- Humidity (%): 45% - 70%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12 hr dark/ 12 hrs light

IN-LIFE DATES: From: 1992-09-24 To: 1992-12-16

Administration / exposure

Type of coverage:
occlusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: approximately 10% of total body surface.
- Type of wrap if used: melolin dressing with adhesive tape, Poroplast and Sleek

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Substance was wiped with wet tissue paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

VEHICLE - none.
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Five per sex per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: four times on the day of treatment, then once daily for the remainder of the study. Weights were recorded on days 0, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, thoracic and abdominal viscera were noted and tissue samples were retained.
Statistics:
Two-sided pooled two sample t-test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: absence of mortality in tested animals
Mortality:
No mortality was reported in this study
Clinical signs:
From day 5 post treatment scab formations (over the treated areas) were observed in four out of five male and two of five female treated rats. These lesions remained to day 14 of the study but were not of sufficient severity to warrant closer observation or early necropsy.

Red staining around the nose and eyes, and on the head was observed throughout the study period in control and test animals. Some rats were found with minor skin damage on the ventral surface of the abdomen. Both of these conditions were ruled to be not related to treatment.
Body weight:
There were no statistically significant changes in body weight and body weight gains for both females and males throughout the study.
Gross pathology:
No abnormalities of the abdominal or thoracic viscera were observed in either treated or control treated animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the absence of mortality, lack of clinical toxicity, and absence of significant changes in body weight the median lethal dose was calculated to be >2000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity study, groups of five male and five female young adult Sprague-Dawley rats were dermally exposed to Paraffin wax for 24 hours to approximately 10% of body surface at a dose of 2000 mg/kg body weight. Animals then were observed for 14 days.

The test article caused slight skin irritation reactions in a majority of treated animals which persisted throughout the study. However, a previous study performed at BIBRA (Report No.1091(3)/1/93) demonstrated that SX30 is only a mild irritant and has no corrosive (irreversible) properties when applied to intact rabbit skin for 4 hours. Based on the absence of mortality, minimal clinical observations, standard body weight and weight gain, and necropsy results, the median lethal dose was calculated to be > 2000 mg/kg body weight.

This study received a Klimisch score of one and is classified as reliable without restrictions because it was carried out according to OECD TG 402.