Reaction products of alcohols, C11-14-iso, C13 rich and phosphorus pentoxide

Endpoint summary

Description of key information

Acute oral toxicity LD50 (cut-off value): 5000 mg/kg bw (rat, OECD TG 423)

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

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)

Version / remarks:

17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Animals
- Sprague Dawley
- Source: in-house bred animals
- Body Weight Range at Receipt: 160.37 g to 176.61 g
- Age at Treatment:10 to 11 weeks

Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 19.1-22.9 °C
- Relative humidity: 41-69%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 12-15 x / hour
- Free access to Altromin maintenance diet for rats and mice
- Free access to tap water
- The animals were kept in groups in standard polypropylene c
- Adequate acclimatisation period (at least five days) under laboratory conditions

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

see detaails on study design

Doses:

Prior to the administration a detailed clinical observation was made of all animals. Healthy young adult animals used for Step-I, Step-I confirmation, Step-II and Step-II confirmation were acclimatized for five, seven, eight and twelve days respectively to laboratory condition prior to treatment and were observed for clinical signs once daily.Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
The test item was administered by oral gavage as a single dose of 300 mg/kg body weight (a dose volume of 10 mL/kg body weight) to three female rats in Step I. No clinical signs of toxicity and mortality observed at 300 mg/kg body weight in Step I. Hence, as per the decision rules governing the sequential procedure presented in the OECD 423 test guideline Annex 2c, Step I confirmation was conducted using three more female rats approximately after 24 hours of observation by administering a single dose of 300 mg/kg body weight of the test item. No clinical signs of toxicity and mortality observed at 300 mg/kg body weight in Step I confirmation. Hence, as per the decision rules governing the sequential procedure presented in the OECD 423 test guideline Annex 2c, Step-II was conducted using three more female rats approximately after 24 hours of observation by administering a single dose of 2000 mg/kg body weight. No clinical signs of toxicity and mortality were observed. Hence, as per the decision rules governing the sequential procedure presented in the OECD 423 test guideline Annex 2c, Step-II confirmation was conducted using additional three female rats approximately after 48 hours of observation.

No. of animals per sex per dose:

3 female animals per step per dose- 2 doses performed

Control animals:

no

Details on study design:

The animals were dosed in a stepwise procedure with three female animals per step. The LD50 of the test item was not available, a starting dose of 300 mg/kg body weight (10 ml/kg BW) was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight. The test item was administered by oral gavage as a single dose of 300 mg/kg body weight to three female rats in Step I. No clinical signs of toxicity and mortality observed at 300 mg/kg body weight in Step I. Hence, as per the decision rules governing the sequential procedure presented in the OECD 423 test guideline Annex 2c, Step I confirmation was conducted using three more female rats approximately after 24 hours of observation by administering a single dose of 300 mg/kg body weight of the test item. No clinical signs of toxicity and mortality observed at 300 mg/kg body weight in Step I confirmation. Hence, as per the decision rules governing the sequential procedure presented in the OECD 423 test guideline Annex 2c, Step-II was conducted using three more female rats approximately after 24 hours of observation by administering a single dose of 2000 mg/kg body weight. No clinical signs of toxicity and mortality were observed. Hence, as per the decision rules governing the sequential procedure presented in the OECD 423 test guideline Annex 2c, Step-II confirmation was conducted using additional three female rats approximately after 48 hours of observation. No clinical signs of toxicity and mortality observed.

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Mortality:

All animals survived until the end of the study without showing signs of toxicity.

Clinical signs:

other: All animals survived until the end of the study without showing signs of toxicity.

Gross pathology:

At necropsy, no macroscopic findings were observed in any animal of any step.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the experiment, it is concluded that the LD50cut off value for the test item is 5000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals (No. 423, Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Acute Toxic Class Method”. “No Classification” (i.e. no acute toxicity hazard category) has to be applied according to Classification, labelling and packaging (CLP) of substances and mixtures as per Regulation (EC) No 1272/2008.

Executive summary:

The test item was evaluated for acute oral toxicity in Sprague Dawley rats as per OECD Guideline No. 423: Acute Oral Toxicity - Acute Toxic Class Method adopted on 17 December 2001. A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I, Step-I confirmation were dosed with 300 mg/kg. Step-II and Step-II confirmation were dosed at 2000 mg/kg body weight of the test item through oral route respectively. No clinical signs of toxicity and mortality was observed at Step-I, Step-I confirmation, Step-II and Step-II confirmation. Based on the results of the experiment, it is concluded that the LD₅₀cut off value for the test item ITD is 5000 mg/kg body weight. “No Classification” (i.e. no acute toxicity hazard category) has to be applied according to Classification, labelling and packaging (CLP) of substances and mixtures as per Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

High quality, GLP study according to OECD TG Guideline

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The submission substance was evaluated for acute oral toxicity in Sprague Dawley rats as per OECD Guideline No. 423. A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I, Step-I confirmation were dosed with 300 mg/kg. Step-II and Step-II confirmation were dosed at 2000 mg/kg body weight of the test item through oral route respectively.No clinical signs of toxicity and mortality was observed at Step-I, Step-I confirmation, Step-II and Step-II confirmation.Based on the results of the experiment, it is concluded that the LD₅₀cut off value for the test item ITD is 5000 mg/kg body weight.“No Classification” (i.e. no acute toxicity hazard category) has to be applied according to Classification, labelling and packaging (CLP) of substances and mixtures as per Regulation (EC) No 1272/2008.

Justification for classification or non-classification

Based on the results from available guideline studies which revealed a LD50 cut-off value of 5000 mg/kg body weight, the registration substance is not subject to labelling and classification requirements with regard to oral exposure.