Petrolatum (petroleum), oxidized, calcium salt

Acute Toxicity: dermal

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:

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

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

Test material information

Constituent 1

Reference substance name:

Paraffin Wax (CAS # 848301-87-1) (For Petrolatum (Non-carcinogenic Feed-stock))

IUPAC Name:

Paraffin Wax (CAS # 848301-87-1) (For Petrolatum (Non-carcinogenic Feed-stock))

Details on test material:

Read Across to Paraffin and Hydrocarbon Wax
- Name of test material (as cited in study report): SX30
- Substance type: Paraffin and Hydrocarbon Wax
- Physical state: solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- 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.

Duration of exposure:

24 hours

Doses:

single dose of 2000 mg/kg

No. of animals per sex per dose:

5 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

Remarks on result:

other: Based on absence of mortality in tested animals

Mortality:

No mortality was reported in this study

Clinical signs:

other: 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

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:

Read across justification

No acute oral toxicity studies have been reported for petrolatum (non-carcinogenic feed-stock), but data have been reported for paraffin and hydrocarbon waxes, materials similar to petrolatum (non-carcinogenic feed-stock).

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.