Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-10-24 to 1990-04-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24 February 1987
Deviations:
no
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 Orange 12

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 8 weeks (mean), females: 10 weeks (mean)
- Weight at study initiation: Males: 180 g (mean), females 172 g (mean)
- Fasting period before study: 16 hours before and 4 hours after treatment
- Housing: Animals were kept in Makrolon cages type III on dust-free wood granules
- Diet (e.g. ad libitum): Altromin R 1324 from Altromin GmbH, Lage, Germany; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
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: weighing: immediately before application, weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
n.a.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No deaths
Clinical signs:
No effects observed
Body weight:
No effects observed. For individual results please refer to Table 1 in box "Any other information on results incl. tables"
Gross pathology:
No effects, except one finding in one male animal (elastic knot in the glandular gastric mucosa).

Any other information on results incl. tables

Table 1: Individual body weights

Males
Females
Animal No. Week Animal No. Week
0 1 2 0 1 2
1 170 212 237 6 167 178 184
2 188 231 266 7 175 186 199
3 176 207 227 8 176 193 201
4 188 231 260 9 170 179 203
5 178 221 242 10 172 192 196
Mean 180 220 246 172 186 197

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study, the LD50 of the test item was determined to be greater than 2000 mg/kg bw in rats.
Executive summary:

In an acute oral toxicity study, young adult Wistar rats (5/sex) were given a single oral dose of the test item at a dose of 2000 mg/kg bw and were observed for 14 days. All animals survived until the end of the study. No effects on body weight and no adverse signs of toxicity were observed. Gross pathology performed on animals revealed no adverse signs, except one finding in one male animal, which showed a elastic knot in the glandular gastric mucosa. Based on the results, the oral LD50 in both male and female rats can be considered to be greater than 2000 mg/kg bw. Based on these results, no classification for acute oral toxicity is warranted according to CLP criteria.