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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-07-13 to 2004-08-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December, 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dithiane-2,5-diol
EC Number:
254-751-6
EC Name:
1,4-dithiane-2,5-diol
Cas Number:
40018-26-6
Molecular formula:
C4H8O2S2
IUPAC Name:
1,4-dithiane-2,5-diol
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Crl; CD® (SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 186.67 ± 20%
- Fasting period before study: overnight
- Housing: groups of three in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum, except the overnight fast before the administration and 3 to 4 h after dosing; Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK
- Water (e.g. ad libitum): ad libitum, except the overnight fast before the administration and 3 to 4 h after dosing
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
BP
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL; 5 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As recommended by OECD guideline
Doses:
one group with 300 mg/kg bw and 2 groups with 50 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to dosing and seven and fourteen days after treatment or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Results and discussion

Preliminary study:
Initially, animals were treated with 300 mg/kg bw. Since all animals died within the first 4 h after administration the dose was reduced to 50 mg/kg bw.
Effect levels
Key result
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 50 - <= 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No premature deaths were observed at a dose level of 50 mg/kg bw
Mortality:
All animals treated at a dose level of 300 mg/kg bw were found dead four hours after dosing. There were no deaths noted in animals treated at a dose level of 50 mg/kg bw.
Clinical signs:
Signs of systemic toxicity noted during the study were hunched posture, lethargy, ataxia and diarrhoea in the 300 mg/kg bw group. The animals treated with 50 mg/kg bw exhibited no clinical signs of toxicity.
Body weight:
No changes in body weight gain were observed.
Gross pathology:
No abnormalties were detected.

Any other information on results incl. tables

Table 1: Mortality data

Dose level mg/kg

Sex

Number of animals treated

Deaths during day of dosing (hours)

Deaths during period after dosing (days)

Deaths

½

1

2

4

1

2

3

4

5

6

7

8-14

300

female

3

0

0

0

3

-

-

-

-

-

-

-

-

3/3

50

female

3

0

0

0

0

0

0

0

0

0

0

0

0

0/3

female

3

0

0

0

0

0

0

0

0

0

0

0

0

0/3

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
In the present study conducted according to OECD guideline 423 (adopted 17 December 2001), GLP, three female Sprague-Dawley rats were administered 300 mg/kg bw of the test substance by oral gavage and observed for 14 days. All animals of this dosage group died within 4h after administration, thus, the dose was reduced to 50 mg/kg bw. No clinical signs of intoxication or premature death were observed in the 50 mg/kg bw dosage group. Based on these results and according to Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) the test substance needs to be classified into Category 3 and labeled with "Toxic if swallowed" with respect to acute oral toxicity.