2,6-dimethyloct-7-en-2-yl acetate

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 401: LD50 >5000 mg/kg bw

Acute dermal toxicity: OECD TG 402: LD50 >5000 mg/kg bw

Acute inhalation (route to route extrapolation): no adverse effect predicted

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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been follo wed but not GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Study pre-OECD guidance. However, the dosing and observations at this time are similar to the OECD 401 test guidance.

Deviations:

not applicable

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

other: oral

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/Kg Body weight

No. of animals per sex per dose:

10 animals

Control animals:

not specified

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured

Clinical signs:

other: none

Interpretation of results:

other: Not acute harmful.

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

An LD50 of >5000 mg/kg bw was calculated in the acute oral toxicity study with rats.

Executive summary:

In an acute oral toxicity study a group of 10 rats were orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured and no clinical signs were observed.

Based on the results, an LD50 of >5000 mg/kg bw was calculated in the acute oral toxicity study with rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 October 1979 - 30 October 1979

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

No data on environmental conditions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: TacN (SD) fBR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms (Germantown, N.Y.)
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: males: 200 - 237g; females: 182 - 207g
- Fasting period before study: no
- Housing: The animals were housed singly in wire cages.
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Range finding test: Two rats of each sex were used per dose. Each animal received a single dose of the test substance. Rats were observed for the next 72 hours to determine the mortality. In other respects the test system was similar to that described below. The doses were 50, 160, 500, 1600 or 5000 mg/kg bw.

TEST SITE
Experimental procedure:
On the day prior to treatment, the backs of the rats were clipped from the scapular region to the hips using an Angra clipper blade. Before application, a non-lubricated condom with the closed end cut off was slipped over the tail and hind legs, and it was adjusted to cover the trunk between the shoulder girdle and the hips. The test substance was applied evenly over the back using a B-D disposable syringe and a 14G gavage needle.
- Type of wrap if used: 2 inch elastic adhesive bandage (Elastikon)

REMOVAL OF TEST SUBSTANCE
- Washing: None, the excess material was removed by wiping with a dry cloth.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 5.75 mL/kg bw

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy of survivors performed: Yes, all the animals underwent a gross necropsy at the end of the experiment. The animals were killed using ether.

Preliminary study:

In a preliminary assay two rats of each sex were treated by application of the test substance to the skin at 50, 160, 500, 1600 or 5000 mg/kg bw. There were no deaths during the 72 hour observation period.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the s

Gross pathology:

There were no signs indicative of toxicity in any of the 12 animails necropsied at termination.

Interpretation of results:

other: Not acute harmful.

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

An LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.

Executive summary:

In an acute dermal toxicity study a group of 12 rats (6 males and 6 females) were dermally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured. The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the study.

Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute dermal toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral (Key study):

In an acute oral toxicity study a group of 10 rats were orally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured and no clinical signs were observed. Based on the results, an LD50 of >5000 mg/kg bw was calculated in the acute oral toxicity study with rats.

Supporting study: In another study with limited information an LD50 > 10 mL per kg body weight was found (record not included).

Acute inhalation

Acute inhalation: Acute inhalation is predicted based on the acute oral toxicity in accordance with the ECHA CLP guidance document (2015, 3.1.3.3.4: 1 mg/kg bw = 0.0052 mg/l (5.2 mg/m3).

The acute inhalation is predicted to be:

LC50=5000 x 5.2 x 50/100 = 13000 mg/m3 (using 100% inhalation and 50% oral absorption).

The calculated saturated vapour pressure is 1563 mg/m3 (MW*VP/ 8.3 (gas constant)*293oK). This means that the acute inhalation concentration cannot be reached and therefore no acute inhalation is anticipated.

Acute dermal

In an acute dermal toxicity study a group of 12 rats (6 males and 6 females) were dermally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured. The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the study. Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.

Justification for classification or non-classification

The substance does not need to be classified for acute oral, dermal and inhalation toxicity according to EU CLP (EC No. 1272/2008 and its amendments).