Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Lime Oxide
- Molecular formula: predominantly a mixture of monoterpenes C10H16 and cyclic monoterpene ethers C10H18O
- Molecular weight: monoterpenes C10H16 molecular weight 136.2, cyclic monoterpene ethers C10H18O molecular weight 154.2
- Physical state: clear colorless liquid
- Analytical purity: 61.8%, sum of 4 major peaks
- Impurities: Known impurities are similar in nature to the major components and have empirical formulae of either C10H16 or C10H18O
- Lot/batch No.: SC00009577
- Expiration date of the lot/batch: 13 October 2015
- Storage condition of test material: room temperature, in the dark
Specific details on test material used for the study:
The study report states that Lime Oxide is Hydrogenated.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Dose ranging rats were were housed singly and main study rats were housed 5 to a cage by sex.
The mean environmental maximum and minimum temperatures during the main study were 22'C and 20'C, respectively and mean relative humidity was 59%.
A 12 hour light/dark cycle was in operation with 15-20 air changes per hour.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
The test material was administered orally in a single dose by means of a gavage at a constant dose volume of 10 mL/kg.
Doses:
Dose Range: 5, 50, 500 and 2000 mg/kg.
Main: One group of males and females were dosed at 2000 mg/kg.
No. of animals per sex per dose:
5 males and 5 females.
Control animals:
no
Statistics:
Not required as there were no clinical observations.

Results and discussion

Preliminary study:
No clinical observations.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality observed.
Clinical signs:
No clinical observations.
Body weight:
No body weight changes observated.
Gross pathology:
No gross pathology observated.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the LD50 is greater than 2000 mg/kg.
As no clinical signs or mortality was observed, no classification is required.
Executive summary:

Under the conditions of the study, the LD50 is greater than 2000 mg/kg.