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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): GASIR1
- test material was ground using a Retsch Centrifugal Ball Mill and passed through a 250 µm sieve before use.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 194-223g
- Fasting period before study:overnight before dosing
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle:no data
- Amount of vehicle (if gavage):no data
- Justification for choice of vehicle:the test material did not dissolve/suspend in distilled water

MAXIMUM DOSE VOLUME APPLIED:
The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing.
Doses:
175, 550, 2000
No. of animals per sex per dose:
175mg/kg: 1
550mg/kg: 1
2000mg/kg: 3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30min, 1, 2 and 4 hours after dosing and subsequently once daily for 14days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Body weight: prior to dosing and seven and fourteen days after treatment

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 550 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 175 mg/kg bw; Number of animals: 1; Number of deaths: 0
Clinical signs:
other: Hunched posture was noted in the animal treated at a dose level of 550mg/kg. Signs of systemic toxicity noted in two animals treated at a dose level of 2000mg/kg were hunched posture and pilo-erection. There were nog signs of systemic toxicity noted in th
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

Individual bodyweights and weekly bodyweight changes

             
 Dose level mg/kg  Animal number and sex  Bodyweight (g) at day        Bodyweight gain (g) during week   
     0 7  14  1  2 
 175  1 -0 Female  201 239  244 38  5 
 550  2 -0 Female  194 209  224  15  15 
 2000  3 -0 Female  197  239  249  42  10
2000   4 -0 Female  223  255  260  32  5
 2000  5 -0 Female  203  246  272  43  26

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

See attached documents.