Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with guideline OECD423 and EU B.1 and to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Decane-1,2-diol
EC Number:
214-288-2
EC Name:
Decane-1,2-diol
Cas Number:
1119-86-4
Molecular formula:
C10H22O2
IUPAC Name:
decane-1,2-diol
Test material form:
other: white solid
Details on test material:
- Name of test material (as cited in study report): 1,2-decanediol
- CAS number: 1119-86-4
- EC number: 214-288-2

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Test animal: Sprague-Dawley CD (Cr1: CD® ( SD) IGS BR Strain)
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: Approximately eight weeks old
- Weight at study initiation: 182 to 282g. All females were below guideline value of 200g but this is not considered to have affected the outcome of the study
- Fasting period before study: Overnight before study
- Housing: The animals were housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access food (Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK)
- Water (e.g. ad libitum): Free access to mains drinking water a
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C a
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200mg/mL
- Amount of vehicle (if gavage): 10mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not reported - the highest of the 4 dosage levels on the OECD/EU test guideline was used.

Doses:
2000 mg/kg
No. of animals per sex per dose:
Three males and three females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30minutes, 1 hour, 2 hours and 4 hours post dosing and then daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs daily, body weight prior to dosing and on days 7 and 14 pot dosing, gross pathology on necropsy:
Statistics:
Not reported

Results and discussion

Preliminary study:
Not reported
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The LD50 of 2500 is based on the flow chart from the acute toxic class method for no mortality in either of the sexes tested.
Mortality:
There were no deaths.
Clinical signs:
Signs of systemic toxicity noted in all males during the day of dosing were hunched posture and lethargy. All males appeared normal one day after dosing. There were no signs of systemic toxicity noted in females.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: EU CLP
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Cr1: CD® ( SD) IGS BR) strain rat was estimated from the flow chart Annex 3d of OECD Test guideline 423 as being greater than 2500 mg/kg bodyweight.

The test material does not meet the criteria for classification according to EU CLP labelling regulations for acute toxicity..
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD (Cr1: CD® ( SD) 1GS BR) strain rat. The method was designed to meet the requirements of the following: a) OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity — Acute Toxic Class Method" (adopted 22 March 1996) and b) Commission Directive 96/54/EC Method B1 tris Acute Toxicity (Oral) — Acute Toxic Class Method Method. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths.

Signs of systemic toxicity noted in all males during the day of dosing were hunched posture and lethargy. There were no signs of systemic toxicity noted in females. All animals showed expected gains in bodyweight over the study period and no abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD® (SD) 1GS BR) strain rat was estimated from the flow chart Annex 3d of OECD test guideline 423 as being greater than 2500 mg/kg bodyweight.

The test material does not meet the criteria for classification for acute toxicity according to EU CLP labelling regulations.