Nerol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study conducted similarly to OECD Guideline 401 with deviations: purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not weighed after dosing; gross pathology not reported

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not weighed after dosing; gross pathology not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Nerol

EC Number:

203-378-7

EC Name:

Nerol

Cas Number:

106-25-2

Molecular formula:

C10H18O

IUPAC Name:

3,7-dimethylocta-2,6-dien-1-ol

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Compound No. 71-53
- Physical state: Clear liquid
- Date of receipt: 11 April 1972

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period during the study: Animals were fasted for a minimum of 16 h prior to administration of the test item.
- Diet: Food, ad libitum
- Water: Water, ad libitum

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Test material was administered as a concentrate.

Doses:

2560, 4000, 6250 and 9800 mg/kg bw

No. of animals per sex per dose:

10 males/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made at 1 and 6 h after dosing and daily thereafter for 14 days.
- Necropsy of survivors performed: Yes; all surviving animals were sacrificed for gross necropsy examination.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 500 mg/kg bw

Based on:

test mat.

95% CL:

3 400 - 5 600

Remarks on result:

other: Deaths occurred overnight to two days following administration of test item. 1/10, 4/10, 7/10 and 10/10 animals were died at 2560, 4000, 6250 and 9800 mg/kg bw, respectively.

Mortality:

- Deaths occurred overnight to two days following administration of test item.
- 1/10, 4/10, 7/10 and 10/10 animals were died at 2560, 4000, 6250 and 9800 mg/kg bw, respectively.

Clinical signs:

other: - Exophthalmia, hyperreflexiveness, restlessness, lethargy and the loss of righting reflex were observed.

Gross pathology:

- No data

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for nerol is higher than 2000 mg/kg bw in rats therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.

Executive summary:

In an acute oral toxicity study performed similarly to OECD Guideline 401, groups (10 males/dose) of Wistar rats were given a single oral dose of nerol at 2560, 4000, 6250 and 9800 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.

Exophthalmia, hyperreflexiveness, restlessness, lethargy and the loss of righting reflex were observed. Deaths occurred overnight to two days following administration of test item. 1/10, 4/10, 7/10 and 10/10 animals were died at 2560, 4000, 6250 and 9800 mg/kg bw, respectively. In this study, the oral LD₅₀ of test item was 4500 mg/kg bw with 95 % confidence limits of 3400 -5600 mg/kg bw in male rats.

The oral LD₅₀ for nerol is higher than 2000 mg/kg bw in rats therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.