Reaction mass of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol and 1-chloro-3-(dodecyloxy)propan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1995

Reliability:

1 (reliable without restriction)

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 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-chloro-3-(dodecyloxy)propan-2-ol

EC Number:

241-661-7

EC Name:

1-chloro-3-(dodecyloxy)propan-2-ol

Cas Number:

17677-15-5

Molecular formula:

C15H31ClO2

IUPAC Name:

1-chloro-3-(dodecyloxy)propan-2-ol

Test material form:

liquid

Details on test material:

pale straw/yellow liquid

Specific details on test material used for the study:

Study was performed long before substance identity was confirmed in detail. It is hence very plausible that this study has not been conducted on 1-chloro-2-hydroxy-3-(n-dodecoxy)propane, but on the registered substance 'Reaction mass of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol and 1-chloro-3-(dodecyloxy)propan-2-ol'. In this view, the study was found relevant for this registration.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles Rivers UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 183 to 222 g (males) and 131 to 192 g (females)
- Housing: housed on grids
- Diet (e.g. ad libitum): commercially available standard 17% rat/mouse pelleted diet - ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25°C
- Humidity (%): 34-80 %
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

for the diluted administrations only

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Not specified
- Amount of vehicle (if gavage): 1 mL/100 g body weight

MAXIMUM DOSE VOLUME APPLIED: 10,000 mg/kg bw

- Rationale for the selection of the starting dose: range finding study performed at 10,000 mg/kg bw

Doses:

2000, 5000 and 10,000 mg/kg bw

No. of animals per sex per dose:

5 per sex and per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 20 to 40 minutes post dosing and 1,2,3 and 4 hours post dosing, and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

not necessary

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

Only 1 death in the high dose group - no gross abnormalities were observed at post-mortem examination.

Clinical signs:

No abnormal signs were reported in the low dose group (2000 mg/kg bw). In the intermediate group a decrease in activity was observed at start, but after 4 days no abnormal signs observed. In the higher dose groupthe decrease in activity was more important. Moreover, the body coats appeared oily.

Body weight:

Normal weight gain was observed.

Gross pathology:

Only abnormalities seen at end (14 days) in necropsies was for female rats (high dose): stomach slightly compacted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance appears not to be toxic via oral route, with an LD50 value of > 10,000 mg/kg bw for females and males.

Executive summary:

An acute oral toxicity study has been performed on 1 -chloro-2 -hydroxy-3 -(N-dodecoxy) propane, according to OECD 401 (1987) and Method B.1 of 92/69/EEC.

Oral toxicity to Sprague Dawley CD rats following single dose administration via oral gavage in corn oil to 4 groups of 10 rats (5 male and 5 female per group) was assessed. The administered doses were: control, 2000, 5000 and 10,000 mg/kg bodyweight. During the main study, one female rat died at the highest dose on day 9. Animals treated with 10,000 mg/kg bw had slightly oily coats. All animals showed decrease in activity. Necropsis at day 14 showed that the females dosed with 10,000 mg/kg bw had sightly compacted stomach.

The LD50 was found to be >10,000 mg/kg bw (females, males and combined).

Study was performed long before substance identity was confirmed in detail. It is hence very plausible that this study has not been conducted on 1-chloro-2-hydroxy-3-(n-dodecoxy)propane, but on the registered substance 'Reaction mass of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol and 1-chloro-3-(dodecyloxy)propan-2-ol'. In this view, the study was found relevant for this registration.