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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
not GLP
Justification for type of information:
This information is used for read-across to Neryl acetate multi

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:
no details on test material (purity not indicated), no details on environmental conditions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Neryl acetate
EC Number:
205-459-2
EC Name:
Neryl acetate
Cas Number:
141-12-8
Molecular formula:
C12H20O2
IUPAC Name:
(2Z)-3,7-dimethylocta-2,6-dien-1-yl acetate

Test animals

Species:
rat
Strain:
other: Charles River strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Age at study initiation: Not specified
- Weight at study initiation: 200 to 300 g.
- Fasting period before study: yes, 18 hours
- Housing: housing in raised wire mesh cages in air conditioned room
- Diet: Free acces to Lab Blox
- Water: Free access to tap water.
- Acclimation period: Not specified

ENVIRONMENTAL CONDITIONS
Not specified

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
GAVAGE METHOD: Rigid stomach tube

Frequency: single dosage

MAXIMUM DOSE VOLUME APPLIED:
5 mL/kg body weight.
Doses:
5 mL/kg bw.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 555 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
other: No clinical signs were observed.
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not acutely harmful.
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The oral acute LD50 is >4555 mg/kg bw in male and female rats.
Executive summary:

The oral acute toxicity of Neryl Acetate (‘mono’) was investigated in a study comparable to OECD TG 401 (non-GLP). In this study, 5 male and 5 female rats were administered a single oral dose of 5 mL (4555 mg/kg bw based on a relative density of 0.911) by gavage followed by a 14-day observation period. No mortality or other signs of toxicity were observed throughout the test. No clinical signs were noted. Based on these findings, the acute oral LD50 of Neryl Acetate (‘mono’) was determined to be >4555 mg/kg bw.