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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994
Reference Type:
other: Supplemental report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MAFF Acute Oral Toxicity Study
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
124495-18-7
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Substance ID: TSN 100097
- Name of substance: XDE-795
- Lot number: DECO-97-152-1
- Purity: 97.4%

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc., Kingston, New York
- Age at study initiation: 8 weeks
- Weight at study initiation: Males: 173.6 ± 4.5 g; Females: 120.8 ± 2.5
- Housing: Housed two or three per cage
- Fasting period before study: All animals were fasted the night before treatment
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Careful in-life observations were made frequently the day of treatment and at least once each working day throughout the two-week observation period. All in-life observations were recorded. Each surviving animal was weighed, pre-study, the day of treatment, and on test days 2, 8 and 15.
- Necropsy of survivors performed: Yes
Statistics:
Means and standard deviations of body weights were calculated. The data were evaluated for statistical outliers by a sequential test, however, they were not routinely excluded from statistical analysis. All animals survived at the limit dose of 5000 mg/kg therefore no LD50 calculation was performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limit dose
Mortality:
All rats survived the two week observation period
Clinical signs:
other: Clinical observations included urine and fecal soiling in the perineal area, and decreased activity
Gross pathology:
No treatment-related observations were made at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 (rat): > 5000 mg/kg (limit dose)
Executive summary:

The test substance was evaluated for oral toxicity following OECD guideline 401 and US EPA 81-1. Five male and female Fischer 344 rats received 5000 mg/kg of test substance as a 50% suspension in corn oil by single-dose oral gavage. Parameters evaluated during the two-week observation period included body weights and in-life observations. All animals were examined for gross pathological changes.

All rats survived the 5000 mg/kg limit dose established by the guidelines and therefore no other dose levels were tested.

Clinical observations included urine and fecal soiling in the perineal area, and decreased activity. All rats gained body weight during the two-week observation period. No treatment-related observations were made at necropsy.

Under the conditions of this study, the acute oral LD50 of the test substance for male and female rats were greater than the limit dose of 5000 mg/kg.