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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From May 18 to June 08, 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
Source study has reliability 1. Details on the read across are attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December 2001
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01
Test material form:
not specified

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.
- Females: animals were nulliparous and non-pregnant.
- Age at study initiation: eight to twelve weeks of age.
- Weight at study initiation: bodyweights fell within an interval of ± 20 % of the mean initial bodyweight of the first treated group.
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Housing: animals were housed in groups of three In suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, ad libitum.
- Wate: ad libitum.
- Acclimation period: at least five days.

FOOD AND WATER QUALITY
The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 30 - 70 %
- Air changes: at least fifteen changes per hour.
- Photoperiod: the 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:
water
Details on oral exposure:
- Concentration: 200 mg/ml
- Volume: 10 mg/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 rats
Details on study design:
- Procedure: treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.
- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Frequency of weighing: individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: at the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
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:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 (female) > 2000 mg/kg bw
Executive summary:

The study was perfomed to assess the acute oral toxicity of test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed according to OECD guidelines 423 and EU method B1 tris. A group of three fasted females was treated with test material at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females at the same dose level.

Test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths during the experiment; no signs of systemic toxicity was recorded. All animals showed expected gains in bodyweight over the study period.

No abnormalities were noted at necropsy.

Conclusion

The acute oral median lethal dose (LD50) of test material in female Sprague-Dawley CD strain rats was estimated to be greater than 2000 mg/kg bodyweight.