Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 1982 - Jan 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Orange 64

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 (male) - 14 (female) weeks
- Weight at study initiation: 161 - 183 g (male) and 158 - 187 g (female)
- Females: nulliparous and not pregnant
- Fasting period before study: 16 h
- Housing: Makrolon type 3 cage with softwood bedding
- Diet (e.g. ad libitum): Altromin®1324 Pellets ad lib. 4 h after dosing
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Application volume: 20 mL/kg bw
Doses:
2000 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: four times during day 1, twice per day during days 2-15 (once per day during weekend)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behaviour
Statistics:
N/A

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:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occured
Clinical signs:
5000 mg/kg bw: bad general condition, nausea (all symptoms occurred between 1 and 24 h after application)
1000 mg/kg bw: no symptoms
Body weight:
No effect on body weight gain
Gross pathology:
No macroscopic findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) was determined to be >5000 mg/kg in female/male rats. The substance does not meet the classification criteria according to the CLP Regulation.