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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, OECD guideline conform, read across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
440-520-9
EC Name:
-
IUPAC Name:
440-520-9

Test animals

Species:
rat
Strain:
other: HanBrl: Wist (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fuellinsdorf / Switzerland
- Age at study initiation: males = 8 weeks, females = 10 weeks
- Weight at study initiation: males = 187.7 - 210.4 g, females = 181.5 - 184.9 g
- Fasting period before study: 16 to 20 hours
- Housing: three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 77/01 (Provimi Kliba AG, Kaiseraugst/ Switzerland) ad libitum.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: PEG 300
Details on oral exposure:
VEHICLE
- Lot/batch no. (if required): 430424/1 54701 (animal nos. 1-3), 430424/1 25001 (animal nos. 4-6)

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were noticed daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded. Weighing was done on test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
Not necessary

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the study.
Clinical signs:
No clinical signs were noted during the course of the study.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion