Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
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.