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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:
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.

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