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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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

Constituent 1
Reference substance name:
Lime Oxide
IUPAC Name:
Lime Oxide
Constituent 2
Reference substance name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
EC Number:
277-225-8
EC Name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
Cas Number:
73018-51-6
IUPAC Name:
1,6-octadien-3-ol, 3,7-dimethyl-, acid-isomerized
Constituent 3
Reference substance name:
Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
IUPAC Name:
Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
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 or test system 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:
other: No clinical observations.
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.