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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Remarks:
Test substance is one component of the target (UVCB) substance; it is one of the major components, ranging between 10 - 60 % w/w. Other components show slight differences in terms of position / type of functional groups.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliability 2. Details on the read across are available in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Principles of method if other than guideline:
Male and female rats were dosed by gavage and observed over a period of 7 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Similar Substance 01_DR89_1
IUPAC Name:
Similar Substance 01_DR89_1

Test animals

Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night
- Housing:in groups of 5
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 50 %

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 % suspension in carboxymethyl-cellulose 2 %

Doses:
1000, 2150, 3170 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy and autopsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 170 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
3 170 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
other: Within 2 h after treatment, all animals showed dose related sedation, dyspnoea, exophthalmus, curved position amd ruffled fur. Recovery occurred within 6 days.
Gross pathology:
No substance related gross organ changes.

Any other information on results incl. tables

dose mg/kg conc. % of formulation no. of animals died within
2 h 24 h 48 h 7 d
M F M F M F M F M F
1000 10 5 5 0 0 0 0 0 0 0 0
2150 10 5 5 0 0 0 0 0 0 0 0
3170 10 5 5 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 > 3170 mg/kg in rats
Executive summary:

Method

Acute oral toxicity was assessed in rats upon administration of a single oral dose. Male and female rats were dosed 1000, 2150 and 3170 mg/kg. Observations were continued up to day 7.

Results

No mortality was seen, thus LD0 = 3170 mg/kg and LD50 > 3170 mg/kg.

Dose related symptoms in terms of sedation, dyspnoea, exophthalmus, curved position and ruffled fur were noted. Recovery within 6 days occurred.