Hydroxylamine

Endpoint summary

Description of key information

For hydroxylamine (free base) no data is available. However, valid studies of the corresponding salts "hydroxylamine sulfate" and "hydroxylamine chloride" are available:
Short Summary:
CAS No. 10039-54-0:
Skin 
In vivo
- Rabbit, 20 h, occlussive: irritating (slight to moderate erythema effects, fully reversible within 8 days; Draize; BASF AG 1969, comp. OECD 404)
- Rabbit, 20 h, occlussive: not irritating (BASF 1956, Val. 3)
- Rabbit, 20 h, occlussive: not irritating (BASF 1969, Val. 3)
- Rabbit, 4 h, semiocclussive: not irritating (RCC Notox 1989, Val. 4)
Eye
In vivo
- Rabbit, 24 h, substance was not washed out: not irritating (slight effects for conjunctivae redness, chemosis and cornea opacity, all fully reversible within 72 h; Draize, BASF AG 1969, comp. OECD 405, Val. 2)
- Rabbit, 24 h, substance was not washed out: not irritating (slight conjunctiva effects, fully reversible within 48 h; Draize, (BASF 1956, comp. OECD 405, Val. 2)
- Rabbit, 24 h, substance was not washed out: not irritating (slight conjunctiva effects, fully reversible within 48 h; Draize, (BASF 1975, Val 3)
- Rabbit, 24 h, substance was not washed out: irritating (Moderate to severe effects on conjunctiva redness and chemosis, fully reversible within 7 days; Draize, (RCC Notox 1989, Val. 4)
Respiratory system
No data available.
CAS No. 5470-11-1:
Skin 
In vivo
- Rabbit, 20 h, occlussive: not irritating (slight erythema effects, fully reversible within 5 days; Draize; BASF AG 1975, Val. 2)
Eye
In vivo
- Rabbit, 24 h, substance was not washed out: irritating (Moderate to severe eye irritation effects including the occurence of staphyloma in two cases; partially not fully reversible at the end of the observation period after 8 days; Draize (BASF AG 1975, Val. 2)
Respiratory system
No data available.

Additional information

For hydroxylamine (free base) no data is available. However, valid studies of the corresponding salts "hydroxylamine sulfate" and "hydroxylamine chloride" are available:

Discussion:

 

CAS No. 10039-54-0:

Human data:

Human experience with local irritation/corrosion caused byhydroxylammonium sulfate is mentioned in the literature but respective reports are not available.Pellerat and Chabeau reported clinical skin irritation tests using concentrations of 1 and 2% hydroxylamine (no details on method given) with 34 persons, who had not been contacted to the substance earlier, 41% of these persons showed positive results (no further details provided (Pellerat and Chabeau 1976, Val. 4).

Animal data:

There are valid in vivo animal data available for the assessment of the skin and eye irritation potential of hydroxylammonium sulfate.

Skin

A Draize test was performed with White Vienna rabbits. A 20-hour occlusive exposure to ca. 2 g of the test substance (moistured with water and mixed to a paste) producedmean scores for erythema of 2.5 for animal 1 (male) and 2.0 for animal 2 (female), regarding the readings after 24 h and 48 h. The mean scores for edema for all animals were 0. Scaling was seen in both animals on day 6. The effects observed were fully reversible at the end of the observation period on day 8(BASF AG 1971, Val. 2).

In a second report, two rabbits were exposed to test material, administered as a 40 % aqueous solution for 20 h under occlusive conditions. A spot-like redness was reported at 24 h reading time point, but without appropriate score in both animals, which was fully reversible after 48 h after application of the test material. The mean score for edema was 0 for all animals at any reading time point (BASF 1956, Val. 3).

In one further report, also with with limited validity, no irritating effects were seen (BASF 1969, Val. 3), whereas irritating effects were seen in another report, also with limited validity (RCC Notox 1989, Val. 4).

Eye

A Draize test was performed with twoWhiterabbits, comparable to OECD guideline 405. Eyes were left unwashed after application of one sharp-edged spoon (ca. 50 mg) of the undiluted, solid test substance and were observed for 8 days. The mean score for conjunctivae redness was 0.66 in both animals, but was reversible within 72 h. The score for cornea was 0.33 in both animals, but was reversible within 48 h. The score for chemosis was 0.33 or 0.66, but was reversible in both animals within 48 h. The iris score was 0 at any reading time point in the treated eyes (BASF AG 1969, Val. 2).

No irritating effects were also observed in a second study, comparable to OECD guideline 405. Eyes of two rabbits were left unwashed after application of the test material and were observed for 72 hours. A score of 0.5 was obtained for conjunctivae redness in both animals, the effect was fully reversible within 48 hours. No irritating effects were seen for cornea, iris and chemosis at any relevant reading time point used for assessment (BASF 1956, Val. 2).

Two further reports, both with with limited validity, are available. In the first report, no irritating effects were seen (BASF 1975, Val. 3; RCC Notox 1989, Val. 4).

 

 

CAS No. 5470-11-1:

There are valid in vivo data available for the assessment of the skin and eye irritation potential of hydroxylammonium chloride.

Skin

A skin irritation test (BASF test) was performed with White Vienna rabbits which were exposed for 1, 5, 15 min and 20-hours to ca. 1 ml of the test substance, moistured with water and mixed to a paste under occlusive test conditions. Themean scores for erythema after an application time of 20 hours under occlusive conditions were for animal 1 (male) 1.5 and for animal 2 (female) 1.0 regarding the readings after 24 h, and 48h. The mean scores for edema for all animals were 0. The effects observed were fully reversible after 5(BASF AG, 1975, Val. 2).

Eye

Severe irritating effects were observed in a BASF test, comparable to OECD guideline 405. Eyes were left unwashed after application of ca. 50 mg of the undiluted, solid test substance and were observed for 8 days.Moderate to severe eye irritation effects were seen in the treated eyes of the animals, including the occurence of staphyloma in two cases. The effects observed were in some cases not fully reversible at the end of the observation period after 8 days(BASF AG 1975, Val. 2).

Justification for classification or non-classification

According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, Annex VI the classification is:

- Skin Irrit. 2

- Eye Dam. 1

- STOT SE 3 (irritating to respiratory system)

- Xi; R37/38; R41