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Endpoint summary

Description of key information

Acute toxicity of the structural analogue, Guerbetalkohol, after single oral application was tested in female rats, which received up to 2,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 5,000 mg/kg bw. Due to the findings described before (LD50 oral in rats greater than 5,000 mg/kg bw) Licowax R21 S does not have to be classified as acute orally toxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June -July 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-11 weeks
- Fasting period before study: overnight
- Housing: in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 02.06 To: 02.07.2014

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: solubility


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no information on test item

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 3
2000 mg/kg bw: 6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Individual body weights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: yes

Statistics:

none

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be at least 5000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
According to the findings in this study GUERBETALKOHOL does not meet the criteria for classification according to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008.

Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

- Methods

A group of three fasted females was treated with the test item at a dose level of 300 mg/kg body weight. Based on the results from this dose level, further groups of fasted females were treated at a dose level of 2000 mg/kg body weight. Dosing was performed sequentially.

The test item was administered orally as a suspension in arachis oil BP. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

- Results

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Body Weight. All animals showed expected gains in body weight.

Necropsy. No abnormalities were noted at necropsy.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

reliable without restriction

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

 Based on the results of an oral toxicity study the LD50 value for acute oral toxicity was considered to be greater than 5,000 mg/kg bw.

In accordance with REACH “Column 2” in Annex VIII there is sufficient weight of evidence from several independent sources of information leading to the conclusion that Licowax R21 S does not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because   - the LD50 value for acute oral toxicity of Licowax R21 S is greater than 5,000 mg/kg bw  - Licowax R21 S does not have to be classified as skin irritating,  - inhalation to consumer is very unlikely to occur, since the substance is embedded in polymeric matrices for consumer applications and  - inhalation exposure to workers while manufacturing is also considered to be negligible with reference to the physical state (flakes) and low volatility (3.3 X 10-7 Pa) of this substance. Therefore, it is concluded that testing of acute inhalation toxicity of Licowax R21 S is not scientifically necessary.

It can reasonably be deduced that Licowax R21 S does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of a single oral dose of up to 5,000 mg/kg bw in rats. Furthermore the substance does not have to be classified as skin irritating. Due to the combination of its polar character (alcohol function at one end of the molecule) and the long extent of the alkyl chain (at the other end of the molecule) it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.

Justification for classification or non-classification

Due to the findings described in the acute oral toxicity study with the structural analogue, Guerbetalkohol, (LD50 oral in rats greater than 5,000 mg/kg bw) Licowax R21 S does not have to be classified as acute orally toxic. Based on the substance's physico-chemical and non-irritant properties, as well as the unlikeliness of exposures to consumer and workers no higher systemical exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the oral toxicity study. Therefore, Licowax R21 S does not have to be classified as acute toxic.