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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study; short report; no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Deviations:
yes
Remarks:
Limited number of parameters examindéd; sacrifice of animals only after treatment + recovery periods; intermittent treatment
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fettgelb 3G
IUPAC Name:
Fettgelb 3G

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: M: 112 - 140 g; F: 104-128g
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum (Altromin R)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Aqueous starch slurry
Details on oral exposure:
Administration volume: 10 ml/kg bw
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Treatment: 40 days
Recovery: 5-6 days
Frequency of treatment:
30 administrations in 40 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/kg bw
Basis:
actual ingested
Remarks:
Doses / Concentrations:
500 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION : No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes
- Time schedule for collection of blood: before and at the end of the treatment period
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
- Parameters examined: Hemoglobin concentration, red cell count, White cell count, differential cell count

CLINICAL CHEMISTRY: No

URINALYSIS: Yes
- Time schedule for collection of urine: before and at the end of the treatment period
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: Colour, protein, glucose, sediment

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Organs examined: Heart, lung, liver, kidneys, adrenal gland, spleen,

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
not examined
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
CLINICAL SIGNS AND MORTALITY
3 animals (1 at each dose level and 1 control) died during treatment from reasons not connected to the test material

URINALYSIS
male rats showed a physiological increase of protein in urine at the end of treatment

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The repeated administration of test item for 40 days did no induce changes in the parameters examined.
Executive summary:

During a period of 40 days the test item was administered 30 times to groups 10 male and 10 female Wistar rats via gavage. Three groups were treated with 0 (vehicle-control), 100 or 500 mg/kg bw per administration. Animals were killed 5 days after the last treatment.

Result:

No adverse changes were detected in the parameters examined.