Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04-25 April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study performed according to OECD Guideline 423 with minor deviations: temperature and relative humidity were occasionally lower than the minimum optimum values
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
dated 17 December, 2001
Deviations:
yes
Remarks:
temperature and relative humidity were occasionally lower than the minimum optimum values
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
temperature and relative humidity were occasionally lower than the minimum optimum values
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
23 October 2015
Test type:
acute toxic class 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:
3,7-dimethylocta-2,6-dien-1-yl acetate
impurity 1
Chemical structure
Reference substance name:
Geranyl acetate
EC Number:
203-341-5
EC Name:
Geranyl acetate
Cas Number:
105-87-3
Molecular formula:
C12H20O2
IUPAC Name:
3,7-dimethylocta-2,6-dien-1-yl acetate
impurity 2
Reference substance name:
Non identified impurities
Molecular formula:
Not applicable
IUPAC Name:
Non identified impurities
Test material form:
liquid
Details on test material:
Batch No.: 171893
Purity: 90.9%
Name of test material (as cited in study report): neryl acetate
Physical state: colourless to slightly amber liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 9 December 2017
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 171893
- Date received: 22 April 2016
- Manufacturing date: 10 December 2015
- Expiry date: 09 December 2017
- Purity test date: 10 December 2015

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Fridge (6 ± 3°C), darkness

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Used as supplied

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER LABS, France
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 or 9 weeks
- Weight at study initiation: 180-219 g
- Fasting period before study: Food was removed on Day 1 and then redistributed 4 hours after the test item administration.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): Foodstuff (ENVIGO - 2016), ad libitum
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-25°C
- Humidity: 17-70%
- Air changes: At least 10/hour
- Photoperiod: 12 hours dark / 12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSAGE PREPARATION: In the first and the second step of the study, the test item was administered by gavage under a volume of 2.20 mL/kg bw (corresponding to 2000 mg/kg bw, according to the density of 0.911 g/mL supplied by the Sponsor) using a suitable graduated syringe fitted with an oesophageal metal canula.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality were recorded at 30 minutes, 1 hour, 3 hours, 4 hours, and then once daily for 14 days. Animals were weighed on Day 0 (just before administering the test item) and then on Day 2, Day 7 and Day 14.
- Necropsy of survivors performed: Yes; animals were euthanized with sodium pentobarbital on Day 14 and macroscopic observations were noted.
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: A decrease in spontaneous activity (2/6), Preyer’s reflex (1/6) and muscle tone (3/6) was noted in the first hours of the test. The animal recovered a normal activity at 24-hour post-dose.
Gross pathology:
The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 of the test substance is > 2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be > 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the Globally Harmonised System on classification and labelling of chemicals (GHS). No signal word or hazard statement is required.
Executive summary:

In an acute oral toxicity study performed according to Guideline OECD 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was given by oral gavage to a group of 6 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

No mortality occurred during the study. A decrease in spontaneous activity (2/6), Preyer’s reflex (1/6) and muscle tone (3/6) was noted in the first hours of the test. The animals recovered a normal activity at 24-hour post-dose. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment related changes.

Rat Oral LD50 > 2000 mg/kg bw.

Therefore, the oral LD50 of the test substance is > 2000 mg/kg bw in rats. In accordance with Guideline OECD 423, the LD50 cut-off of the test substance may be considered to be > 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the Globally Harmonised System for classification and labelling of chemicals (GHS). No signal word or hazard statement is required.