branched-nonyl 3,5,5 trimethylhexanoate

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

12 - 18 Mar 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Only female animals tested; limited information on test substance and test protocol; observation period only 6 days.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only female animals tested; limited information on test substance and test protocol; observation period only 6 days

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

other: NMRI EOPS

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19-20 g

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 6 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: no data

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the observation period.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Cross-reference 2

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

13 - 19 Mar 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study with acceptable restrictions. No gross necropsy performed, no details on animal husbandry, observation period 7 days in the absence of mortality/signs of toxicity, few details on study protocol, analytical purity not given.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no gross necropsy performed, no details on animal husbandry, few details on study protocol, observation period 7 days in the absence of mortality/signs of toxicity

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

other: NMRI EOPS

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19-20 g (range)

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.8 mL/kg bw, (dose calculated assuming test substance density of 0.8550 g/mL)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days (in the absence of mortality and signs of toxicity)
- Frequency of observations and weighing: mortality was recorded daily; the animals were observed daily for the presence of clinical signs; body weights were determined on Day 0 and 6
- Necropsy of survivors performed: no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 7-day observation period.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Cross-reference 3

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. Few details on study protocol were reported, no individual results were reported, the analytical purity of the test substance was not specified.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

few details on study protocol reported, no individual results reported

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

other: NMRI EOPS

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 20 g

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 4 350 mg/kg bw

Based on:

test mat.

Remarks on result:

other: calculated based on density (0.87 g/cm³)

Mortality:

No deaths occured during the study period.

Clinical signs:

other: No abnormal reaction was observed.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Materials and methods

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Isononyl Isononanoate
- Physical state: liquid

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 4 350 mg/kg bw

Applicant's summary and conclusion

Conclusions:

Based on read-across from the structurally similar substances, the available data on oral toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive67/548/EEC, and are therefore conclusive but not sufficient for classification.

Executive summary:

No acute toxicity data is available for isononyl isononanoate. Therefore, assessment of acute toxicity via the oral and dermal route is conducted by means of read-across. No mortality was observed in acute oral toxicity studies performed with the analogue substances isopropyl laurate (CAS 10233-13-3), 3,5,5 -trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) and isononanoic acid, C16-18 alkyl esters (CAS 111937-03-2) (Dufour, 1991; Dufour, 1991; Masson, 1986; Potokar; 1970). Based on the results of these studies, the overall oral acute LD50 is > 4350 mg/kg bw.