Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April/May 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Yellow 160

Test animals

Species:
rat
Strain:
Wistar
Remarks:
WISKf (SPF71)
Sex:
male/female
Details on test animals and environmental conditions:
- Mean weight:
Male: 176 g and Female: 172 g
- Age:
Male: 7 weeks and Female: 8 weeks
- Room T°: 22 +/- 3°C, Relative humidity: 50 +/- 20%, 12/12 hours light/dark
- Food: Rat diet Altromin 1324, ad libitum; Water: ad libitum
- Food deprivation: 16 hours before and 3 - 4 hours after application

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation:
males : mean = 170.6 g (= 100 %)
min = 167 g (- 2.11 %)
max = 174 g (+ 1.99 %)
females : mean = 172.6 g (= 100 %)
min = 170 g (- 1.51 %)
max = 175 g (+ 1.39 %)
- Fasting period before study: 16 hours before and 2 hours after application
- Housing: in groups of 5 on soft wood bedding
- Diet (e.g. ad libitum): Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45 ± 5
- Air changes (per hr): ca. 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 To: 27. April 1983

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: good water solubility
- Lot/batch no. (if required): NA
- Purity: without contaminants

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:
5000 mg/kg bw in 20 mL/kg bw solution (at a concentration of 25% (W/V)).
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 mortality checks and clinical observations: multiple times on day 1; twice daily thereafter
weighing: weekly
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortalities observed
Clinical signs:
Clinical signs 2 hours after dosing included piloerection and hypoactivity. There were no clinical signs after the first day.
Body weight:
There were no effects on bodyweight.
Gross pathology:
No effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditons, the oral LD50 of the test substance in Wistar rats was determined to be >5000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according OECD Guideline 401 and EU Method B.1, in compliance with GLP. Wistar rats (5 males and 5 females per group) received by gavage 5000 mg/kg bw (at 20 mL/kg at a concentration of 25%). Exposure was followed by a 14 day observation period. Mortality, clinical signs and bodyweight were observed. A gross pathological examination was conducted at test end. No mortality occurred throughout the study. Clinical signs 2 hours after dosing included piloerection and hypoactivity. There were no clinical signs after the first day. There were no effects on bodyweight. At gross necropsy, no abnormalities were noted. Under the study conditions, the oral LD50 of the test substance in Wistar rats was determined to be > 5000 mg/kg bw (based on test material) which equals to > 3000 mg/kg bw based on active ingredient.