Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
- Exophthalmia, hyperreflexiveness, restlessness, lethargy and the loss of righting reflex were observed.
Body weight:
- No data
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.