2,6,10-trimethylundec-9-enal

Endpoint summary

Description of key information

Key study:- Givaudan 1978: Acute oral toxicity, no guideline followed (similar to OECD 401), LD50 > 5 mL/kg bw (male and female rats).

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:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed in accordance with generally accepted scientific principles, possibly with incomplete reporting which do not affect the quality of the relevant results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Test substance name: ADOXAL
appearance: colorless liquid

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adults (Source: Charkes River (UK) Limited, Margate, Kent)
- Weight at study initiation: 165-205 g
- Fasting period before study: over night prior to dosing.
- Housing: In groups by sex, in polypropylene breeding cages.
- Diet/water: Oxoid maintenance diet supllied by Herbert C. Styles (Bewdley) Limited and water were provided ad libitum


ENVIRONMENTAL CONDITIONS
- The cages were places in a thermostatically controlled room under controlled lighting conditions.

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Details on oral exposure:

DOSAGE PREPARATION
For all the dose levels the test material was suspended in vegetable oil on a v/v basis so that the required dose per kilogram was contained in 10 mL.

Doses:

Range finding test: dose levels of 5.0, 2.0, 1.0 and 0.5 mL/kg bw.
Definitive limit test: highest dose level.5.0 mL/kg bw

No. of animals per sex per dose:

Range finding test: groups of two rats (one male and one female)
Definitive limit test: groups of ten rats (five male and five female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed immediately prior to dosing. Animals were examined for overt signs of toxicity immediately after dosing, 4 hours after dosing and then on a daily basis for 14 days.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed in either the range finding or the main study within the 14 day observation period.

Clinical signs:

other: No overt signs of toxicity were observed in either the range finding or the main study within the 14 day observation period.

Table 1: Results

Dose Level (mL/kg bw)	No. of Rats	Sex	Bodyweight	Volume Dosed	Mortality
					0-8 hours	1-7 hours	8-14 hours	Total
5.0	1	Male	180	1.80	0	0	0	0	0
	1	Female	170	1.70	0	0	0	0
2.0	1	Male	170	1.70	0	0	0	0	0
	1	Female	170	1.70	0	0	0	0
1.0	1	Male	205	2.05	0	0	0	0	0
	1	Female	180	1.80	0	0	0	0
0.5	1	Male	195	1.95	0	0	0	0	0
	1	Female	170	1.70	0	0	0	0
5.0	5	Male	190	1.90	0	0	0	0	0
	5	Female	175	1.75	0	0	0	0

 

Interpretation of results:

GHS criteria not met

Remarks:

Not sufficient to be classified under the GHS criteria

Conclusions:

Under the conditions of the test, there were no mortalities observed among any of the animals dosed in this study. Furthermore no overt signs of toxicity were recorded during the 14 day observation period. Based on these observations it was concluded that the LD50 for the test material was greater than 5 mL/kg bw.

Executive summary:

In the key study Givaudan (1978), the acute oral toxicity of the test material was determined in a study where groups of two adult rats (one male and one female) were dose at levels of 5.0, 2.0, 1.0 and 0.5 mL/kg bodyweight in a range-finding study. Based on the results a further group of ten rats (five male and five female) was treated at the highest dose level. Animals were observed for mortality and overt signs of toxicity over a 14 day observation period. The methodology used was similar to that detailed in the OECD 401 guideline. The study pre-dates GLP.

Under the conditions of the test, there were no mortalities observed among any of the animals dosed in this study. Furthermore no overt signs of toxicity were recorded during the 14 day observation period. Therefore based on these observations it was concluded that the LD50 for the test material was greater than 5 mL/kg bw.

 

This study was performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. The study was performed to a good standard however some limitations were present in the level of detail in the reporting of the methods and so was assigned a reliability score of 2 (reliable with restrictions), in accordance with Klimisch (1997) and considered suitable to fulfil the data requirement.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The key study with a Klimisch score of 2 is sufficient for classification determination.

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

Acute Oral Toxicity

In the key study Givaudan (1978), the acute oral toxicity of the test material was determined in a study where groups of two adult rats (one male and one female) were dose at levels of 5.0, 2.0, 1.0 and 0.5 mL/kg bodyweight in a range-finding study. Based on the results a further group of ten rats (five male and five female) was treated at the highest dose level. Animals were observed for mortality and overt signs of toxicity over a 14 day observation period. The methodology used was similar to that detailed in the OECD 401 guideline. The study pre-dates GLP.

Under the conditions of the test, there were no mortalities observed among any of the animals dosed in this study. Furthermore no overt signs of toxicity were recorded during the 14 day observation period. Therefore based on these observations it was concluded that the LD50 for the test material was greater than 5 mL/kg bw.

This study was performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. The study was performed to a good standard however some limitations were present in the level of detail in the reporting of the methods and so was assigned a reliability score of 2 (reliable with restrictions), in accordance with Klimisch (1997) and considered suitable to fulfil the data requirement.

Acute Inhalation Toxicity

In line with Column 2, point 8.5.2, Annex VIII of Regulation 1907/2006, an acute inhalation study does not need to be performed as the substance has a low vapour pressure and the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing the toxicity via the oral , which is more appropriate when considering the properties of this substance.

Acute Dermal Toxicity

An acute dermal toxicity study does not need to be performed as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 oral > 5000 mg/kg bw) and no systemic effects have been observed in the in vivo studies with dermal exposure (skin irritation and sensitization studies).

Justification for classification or non-classification

Acute Oral Toxicity

In accordance with Regulation (EC) No. 1272/2008, the substance does not meet the GHS criteria for classification for acute oral toxicity.