Hydroxylamine-O-sulphonic acid

Endpoint summary

Description of key information

Oral LD50 (rat): > 300 - < 500 mg/kg bw (BASF 2010, according to OECD 423)

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:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

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

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- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum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

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.

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.

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Quality of whole database:

Estimated Klimisch Rating: 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: oral

The acute oral toxicity of the test substance in the rat was examined in a study following the principles of OECD TG 423 (BASF, 2010). Female Wistar rats were given a single oral dose of the solid test substance (300, 500 and 2000 mg/kg bw). Animals were then observed for mortality and for clinical symptoms of toxicity for 14 days. All animals were subjected to necropsy. The oral LD50 was estimated as > 300 - < 500 mg/kg bw. This acute oral toxicity study is classified as acceptable (key study).

 

There are no further data available concerning acute systemic dermal and inhalation toxicity. However, the test substance is regarded as skin corrosive agent, causing local effects.

Justification for selection of acute toxicity – oral endpoint
GLP-conform guideline study.

Justification for classification or non-classification

Based on the results for acute oral (LD50 rat > 300 - < 500 mg/kg bw), the test substance is classified as follows:

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the test substance is considered to be classified for acute oral toxicity and under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014 as follows: acute toxicity: cat. 4, H302, harmful if swallowed.