Saponification and oxidation product of carnauba wax with acidic sodium dichromate solution esterified with 1-methyl-1,3-propanediol and subsequent saponification with calcium dihydroxide

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:

From 15 MAR 2011 to 1 APR 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Version / remarks:

: rational for dose selection was derived here

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

according to Law No.163/2001 Coll and Directive 2004/10/EC

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Carnauba waxes, type E

IUPAC Name:

Carnauba waxes, type E

Details on test material:

- Name of test material (as cited in study report): C-Wax Type E SZ 18 - in this study onward C-wax
- Substance type: yellow coloured powder
- Physical state: solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: accredited breeding Velaz, Prague, Czech Republic
- Weight at study initiation: males: 210-230g, females: 165-200 g
- Fasting period before study:, housed individually in cage after dermal application
- Housing: in groups a 5 per cage
- Diet: standard certified laboratory diet (suplier Biofer Consortium)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 MAR 2011 To: 1 APR 2011

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Remarks:

(refined)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk (fur was removed 24 h before substance applicationby clipping and shaving)
- % coverage: 10% of total body surface area
- Type of wrap if used: porous gauze patch with inserted nonpermeable folio and held in contact with skin by means of a semi-occlusive dressing and non-irritating plaster

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 263 microlitres /100 g of body weight

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: five times within 4 hours after dosing and daily thereafter
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other: observations were performed according to OECD Guidance document No. 19 (GUIDANCE DOCUMENT ON THE RECOGNITION, ASSESSMENT, AND USE OF CLINICAL SIGNS AS HUMANE ENDPOINTS FOR EXPERIMENTAL ANIMALS USED IN SAFETY EVALUATION)

Results and discussion

Preliminary study:

on base of infomration about test compound no preliminary study was performed and limit dose of 2000 mg/kg bw was used as starting dose in main experiment.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occurred

Clinical signs:

other: no systemic signs of toxicity were observed

Gross pathology:

all animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single application of the limit dose of 2000 mg test substance per kg bw onto the skin did not cause lethality in male and female rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Executive summary:

5 male and 5 female Wistar rats were subjected to test acute dermal toxicity (OECD TG 402, Limit test). The test substance was administered on the skin of test animals in a pasteous form in olive oil at the limit dose of 2000 mg/kg bw. All animals were examined for mortality, clinical signs and body weight gain. The pathological alterations of organs were examined at the end of the 14 days observation period. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.

Furthermore no clinical symptoms were observed nor was the body weight gain impaired and no pathological findings were noted.