Hydroxylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Before OECD guideline 404 was established, skin irritation was tested using an internal BASF method. White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5, 15 min and 20 h using occlusive conditions. An application site of 2.5 cm x 2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed for 8 days. Skin reaction was recorded after 1 h, 24 h, 48 h, 72 h, 96 h and after 7 and 8 days.
Differences as compared to OECD TG 404: application time: 1, 5, 15 min and 20 h (OECD: 4 h); 2 animals used (OECD: 1-3); observation period 8 days (OECD: 14); skin changes recorded on working days; dose ~1 ml (OECD: 0.5 ml), additionally testing of the ear (not recomm. by the OECD TG), application under occlusive conditions (OECD: semi-occlusive)

GLP compliance:

no

Remarks:

; GLP was not compulsory at the time the study was conducted.

Test material

Test material information

Constituent 1

Reference substance name:

Bis(hydroxylammonium) sulphate

EC Number:

233-118-8

EC Name:

Bis(hydroxylammonium) sulphate

Cas Number:

10039-54-0

Molecular formula:

H3NO.1/2H2O4S

IUPAC Name:

bis(hydroxyammonium) sulfate

Details on test material:

- Name of test material (as cited in study report): Hydroxylammoniumsulfat
- Physical state: solid
- Analytical purity: pure grade

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male 3.32 kg, female 2.86 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: the untreated sites of the same animal served as control.

Amount / concentration applied:

The test substance (ca. 2 g), moistured with water and mixed to a paste (concentration: 80 %), was applied to a 2.5 cm x 2.5 cm patch

Duration of treatment / exposure:

1, 5, 15 min, 20 hours

Observation period:

The animals were observed following exposure for 8 days on working days. Skin changes were recorded after removal of the bandage after 1 hour as well as after 24 h, 48 h, and on day 6 and 8.

Number of animals:

4 animals (2 animals were used for the 20 h treatments and 2 animals were used for th 1 min, 5 min and 15 min treatments).

Details on study design:

The test substance, moistured with water and mixed to a paste, was applied to a 2.5 cm x 2.5 cm patch (~2 g) and placed on the clipped and intact skin of four white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions.
The right and the left flank of each animal was clipped and the test material was administered on both sites (on the left and on the right site each and each application was scored separately).
The test substance was removed on both sites by washing once. Skin reactions were recorded after 1 h, 24 h, 48 h, and on day 6 and 8. The application time used for assessment was 20 hours, the test material was applied on dorsal skin. The corresponding reading time points used for assessment were 24 and 48 hours after application. Dermal reactions were classified using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation, the BASF scores given in the raw data were converted to Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-48 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: exposure time: 20 h; scale was seen on day 6

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: exposure time: 20 h; scale was seen on day 6

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24-48 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

other: exposure time: 20 h

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24-48 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

other: exposure time: 20 h

Results 5

Irritation parameter:

erythema score

Time point:

24/48/72 h

Remarks on result:

not determinable because of methodological limitations

Remarks:

72-h reading time point was not determined

Results 6

Irritation parameter:

edema score

Time point:

24/48/72 h

Remarks on result:

not determinable because of methodological limitations

Remarks:

72-h reading time point was not determined

Irritant / corrosive response data:

Under the experimental conditions chosen, the mean scores for erythema after an application time of 20 hours under occlusive conditions were for animal 1 (male) 2.5; for animal 2 (female) 2.0, regarding the readings after 24 h and 48 h. No edema was observed in any animal. Scaling was observed on day 6. The effects observed were fully reversible at the end of the observation period on day 8.
In addition, readings were performed in two further animals after exposure times of 1, 5 and 15 min resulting in no effects after 1 and 5 min and a slight erythema (scored 1) after 15 min in both animals.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 based on CLP/EU GHS criteria, according to Regulation (EC) No 1272/2008

Conclusions:

CLP: Skin Irrit, Cat.2, corresponding to the harmonized classification according to Annex VI of CLP Regulation