Hydroxylamine-O-sulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxylamine-O-sulphonic acid

EC Number:

220-971-6

EC Name:

Hydroxylamine-O-sulphonic acid

Cas Number:

2950-43-8

Molecular formula:

H3NO4S

IUPAC Name:

(aminooxy)(hydroxy)sulfane dioxide

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld (Rat / Wistar / CrlGlxBrlHan:WI)
- Age at study initiation: Young adult animals (female animals approx. 14– 18 weeks)
- Weight at study initiation: Animals of comparable weight (200 - 204 grams)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: Single housing
- Diet: Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Olive oil Ph.Eur./DAB

Details on oral exposure:

- Amount of test material applied per gavage: 5.0 mL/kg bw

Doses:

300, 500 and 2000 mg/kg bw

No. of animals per sex per dose:

6 females at 300 mg/kg bw
3 females at 500 and 2000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours, and daily thereafter; Individual weights of animals was determined shortly before the test substance was administered, and at least weekly thereafter

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology.

Statistics:

Not mentioned.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 500 mg/kg bw

Based on:

test mat.

Mortality:

- 300 mg/kg bw; 2. administration: 1/3 animals died after 7 days
- 300 mg/kg bw, 1. administration: No deaths occured until the end of the observation period on day 14
- 500 mg/kg bw: 1 animal died within 48 hours after administration, and one animal died after 7 days.
- 2000 mg/kg bw: 1 animal died within 1 hour after administration, and the two remaining died after 24 h.

Clinical signs:

other: CLINICAL SIGNS: - 2000 mg/kg bw: impaired and poor general state, dyspnoea, abdominal position, staggering (h0 - h2) - 500 mg/kg bw: impaired and poor general state, dyspnoea, staggering, piloerection, smeared fur, exsiccosis, lacrimation, red or orange

Gross pathology:

Animals that died:
- 2000 mg/kg: glandular stomach: multifocal confluent black erosions/ulcers; kidneys, large and small intestine, lung: grey diffuse discoloration; liver: grey or black diffuse discoloration
- 500 mg/kg (2 animals): moderate or bad postmortal state; glandular stomach: few or many black erosions/ulcers, diameter up to 4 mm; stomach: moderate dilation with bloody contents
- 300 mg/kg (1 animal): bad postmortal state, organs without particular findings

Animals examined at the end of the observation period: 500 mg/kg, 1 female; 300 mg/kg, 5 females.
- Organs without particular findings.

Any other information on results incl. tables

Table 1: Summary of mortality data

Dose (mg/kg bw)	number of dead animals (out of 3) after
	1 h	24 h	48 h	7 days	14 days
2000	1	3	3	3	3
500	0	0	1	2	2
300 (1 administration)	0	0	0	0	0
300 (2 administrations)	0	0	0	1	1