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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2003-01-03 - 2003-02-25
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
certified by Ministerium für Raumordnung und Umwelt des Landes Sachsen-Anhalt
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Reference substance name:
Carnauba waxes, type S
Carnauba waxes, type S
Details on test material:
- Name of test material (as cited in study report): Carnauba acid wax (Carnaubawachs, Fettsäuren)
- Physical state: light-yellow powder
- Storage condition of test material: room temperature, closed original container
- Analytical purity:>= 99.5% (w/w)

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River Wiga GmbH, Sulzfeld, Germany (delivered SPF, specific pathogen-free)
- Age at study initiation:ca. 7 weeks
- Weight at study initiation: 198,5 g+/- 5.4 g
- Housing: individual, Macrolon cages Type 3
- Diet (e.g. ad libitum): Altromin 1324, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 7 days
Anomals were randomly selected. Identification of animals by ear marks.

- Temperature (°C): 21 - 21.5 °C
- Humidity (%): 30 -40 % (short-term decrease down to 25%)
- Air changes (per hr): air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Route of administration:
oral: gavage
other: 0.5% Tylose MH 1000 (methyl cellulose) in deminieralised water
Details on oral exposure:
due to poor solubility of the test item in any solvent 0.5% Tylose MH 1000 (methyl cellulose) in deminieralised water was mixed with appropriate amounts of test item to produce a paste. The paste was applied in small amounts into the oral cavity of the rats. Animals were observed during swallowing to avoid any losses of test material.
2000 mg/kg bw
No. of animals per sex per dose:
6 female rats
Control animals:
other: not required
Details on study design:
Animals were fasted 3 h before and 3 h after application. Observation period was 14 d post-application. At the day of application animals were continuously observed for mortality, morbidity and clinical signs (changes of skin, fur, eyes, mucous membranes, gait, posture, respiration, circulation and reaction to handling, secretion and excretion, autonomous activities, tonic or clonic movements and behaviour), afterwards observation was at least once per day.
Body weights were determined at the day of application and at post-application days 7 and 14.
At the end of the observation period all animals were euthanised by CO2. Gross-pathological examinations were performed with body surface, brain, lungs and internal organs of the abdominal cavity.
For body weights group means and standard deviations were calculated and compared to historical control data.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
other: none
Gross pathology:
no treatment-releated changes
Other findings:

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
Under the test conditions (oral application of 2000 mg test item/kg bw) the test item showed no signs of toxicity.
Executive summary:

The acute oral toxicity of the test item was tested in a study according to OECD 423 (acute toxic class method) under GLP conditions. The test item (administered in pasteous form in Tylose and water, due to poor solubility) was administered into the oral cavity of 6 female Wistar rats at a total dose of 2000 mg/kg bw. The animals were observed during swallowing down each portion to avoid loss of test item.

All animals were examined for mortality, clinical signs and body weight gain. The pathological alterations of organs were examined at the end of a 14 -day observation period.

None of the animlas died during the course of investigation. The LD50 p.o. rat is >2000 mg/kg bw.

Clincal symptoms were not observed during the course fo investigation. The body weight gain was not affected. No pathological findings were observed.