6-[methyl(phenylsulphonyl)amino]hexanoic acid

Endpoint summary

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:

1984-12-07 - 1984-12-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, guideline conform GLP study, which meets basic scientific principles

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: HOECHST AG, Kastengrund
- Weight at study initiation:
male: mean 200.1 g
female: mean 184.6 g
- Labelling: coat labelling with KMnO4
- Housing: 5 per cage; air-conditioned
- withdraw of feed: approx. 16 hours before application; 3 - 4 hours after application
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS

- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Route of administration:

oral: gavage

Vehicle:

other: 1,2 propyleneglycol/water

Doses:

1250/ 2000/ 2500/ 3150/ 4000/ 5000 mg/kg

No. of animals per sex per dose:

Dose number of animals
in mg/kg Kgw. male female

1250 - 5
2000 - 5
2500 - 5
3150 5 5
4000 5 -
5000 5 5

Control animals:

no

Details on study design:

The test item was presolved in 12 mL 1,2-Propylenglycol and emulified in 38 mL de-ionized water. The conditioned test item was applicated via gavage. After the application was performed the following parameters were recorded: process of intoxication, rate of lethalityand elapsed time of lethality. Post-observation was carried out for 14 days. Every week the testing animals were weighed. Lethal intoxicated animals were dissected and macroscopic findings were recorded. Those testing animals surviving the post-observation were put to death by CO2. These animals were also dissected and macroscopic findings were recorded.

Sex:

male

Dose descriptor:

LD50

Effect level:

4 540 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50

Effect level:

3 040 mg/kg bw

Based on:

test mat.

Mortality:

Results given in Table 1: Mortality incidence

Clinical signs:

other: Unspecific clinical signs only on the treatment day such as piloerection, ruffled fur, depressed activity, increased respriration etc.

Gross pathology:

Observations in dead males and females: stomach filled with the test substance, intestine filled with clear liquid, damage on the gastro-intestine tissues, bladder filled with liquids, lung filled with bloody liquids.
Observation in dead females only: dark adrenals, pale coloured liver

Table 1: Mortality incidence

Dose	Mortality
mg/kg bw	male		female
	absolute	relative [%]	absolute	relative [%]
1250			0/5	0
2000			0/5	0
2500			1/5	20
3150	1/5	20	3/5	60
4000	1/5	20
5000	3/5	60	5/5	100
LD50	4540 mg/kg bw		3040 mg/kg bw
CL (p = 0.05)	3600 - 6660 mg/kg bw		2410 - 4390 mg/kg bw

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The registration substance was investigated for its acute oral toxicity in rats according to the OECD Guideline 401. The LD50 was determined as 4540 mg/kg bw for males and 3040 mg/kg bw for females. No classification is warranted according to 67/548/EEC (DSD) and Acute Tox. 5 is warranted according to GHS.

Executive summary:

The registration substance was investigated for its acute oral toxicity in rats according to the OECD Guideline 401. The LD50 was determined as 4540 mg/kg bw for males and 3040 mg/kg bw for females. No classification is warranted according to 67/548/EEC (DSD) and Acute Tox. 5 is warranted according to GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Justification for classification or non-classification

The registration substance was investigated for its acute oral toxicity in rats according to the OECD Guideline 401. The LD50 was determined as 4540 mg/kg bw for males and 3040 mg/kg bw for females. No classification is warranted according to 67/548/EEC (DSD) and Acute Tox. 5 is warranted according to GHS.