5-amino-2-chloro-N-(2,4-dimethylphenyl)benzenesulphonamide

Endpoint summary

Description of key information

The LD50 of ACDMA in rat was found to be > 5000 mg/kg bw in test performed according to OECD TG 401 and GLP.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987; October 16 to November 10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1981)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna (UK ) Limited, Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: 171-175g for males; 150-161g for females
- Fasting period before study: overnight fast immediately before dosing and for approximately two hours after dosing
- Housing: groups of up to 5 by sex in solid-floor poly-propylene cages with sawdust bedding
- Diet (e.g. ad libitum): free access to mains drinking water awas allowed throughout the study.
- Water (e.g. ad libitum): free access to food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, t,litham, Essex, U.K.) was allowed throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 45-64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: For the purpose of this study the test material was ground to a fine powder using a mortar and pestle and freshly prepared as required at the appropriate
concentrations i n 1% aqueous carboxymethyl-celIulose.
- Amount of vehicle (if gavage): 10 mL/kg

All rats were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Doses:

Range-finding study: 2000 and 5000 mg/kg bw
Main study: 5000 mg/kg bw

No. of animals per sex per dose:

Range-finding study: 1
Main study: 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 5 days (range-finding study); 14 days (main study)
- Frequency of observations: 1 and 4h after dosing; every days between 1 and 14 days after dosing
- Frequency of weighing: Day 0, 7 & 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Preliminary study:

No death in range-finding study: 0/2 at 2000 mg/kg and 0/2 at 5000 mg/kg

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: greater than the maximum tested concentration

Mortality:

No death: 0/10 at 5000 mg/kg

Clinical signs:

other: No clinically observable signs of toxicity were noted during the study.

Gross pathology:

Necropsy at the end of the study revealed no macroscopic abnormalities.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of ACDMA in rat was found to be > 5000 mg/kg bw in test performed according to OECD TG 401 and GLP.

Executive summary:

The LD50 of ACDMA in rat was found to be > 5000 mg/kg bw in test performed according to OECD TG 401 and GLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed