Registration Dossier

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:
other: Comparable to guideline study without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Rats are treated by gavage with aqueous preparations of the test substance. Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight was determined before the start of the study for determination of dose.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,4-Dichloroaniline-6-sulfonic acid
EC Number:
700-413-2
Cas Number:
6331-96-0
Molecular formula:
C6 H5 Cl2 N O3 S
IUPAC Name:
3,4-Dichloroaniline-6-sulfonic acid
Details on test material:
.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Dr. Thomae GmbH, Biberach, Frg.- Age at study initiation: no data- Weight at study initiation: animal weights were ± 20 g of the average weight- Fasting period before study: 16 hours before administration, no feed was provided. Water was available ad libitum.- Housing: 5 animals/cage in stainless steel wire mesh cages, Type DK-III (Becker & Co., Castop-Rauxel, Frg).- Diet: Kliba Labordiaet 343, Klingenthalmuehle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum- Water: tap water; ad libitum- Acclimation period: at least 1 wk.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20-24- Humidity (%): 30-70- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
[aqueous (0.5%)]
Details on oral exposure:
VEHICLE- Concentration in vehicle: 50%- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium.- Lot/batch no. (if required): no data- Purity: no dataMAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.
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: several time of day of administration, at least once each workday. Check of moribund and dead animals twice each workday and once on holidays.- Frequency of weighing: beginning of test, 7 and 13 days after administration.- Necropsy of survivors performed: yes.- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1% significance level.
Mortality:
None of the animals died.
Clinical signs:
No clinical signs of toxicity were noticed within the 14 day observation window before sacrifice.
Body weight:
Body weight development was normal.Table 1: Mean weight (g) 5,000 mg/kg bwMale animals: At beginning208 After 7 days267 After 14 days 300 Female animals: At beginning 200 After 7 days235 After 14 days240
Gross pathology:
No abnormality was detected.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU