Aluminium nitrate

Endpoint summary

Description of key information

Studies of skin and eye irritation in the rabbit are available for aluminium nitrate

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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: Summary of the primary cutaneous irritation of 56 chemicals in the rabbit using three different procedures

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: method published by the French authorities for the testing of cosmetics and toiletries (Journal Officiel 21 April 1973, p. 3862; 5 June 1973, p. 3953

Qualifier:

according to guideline

Guideline:

other: Association Française de Normalisation (AFNOR)

Principles of method if other than guideline:

The primary cutaneous irritation of 56 chemicals was tested in the rabbit using three different procedures. The three protocols selected for the tests were the method published by the French authorities for the testing of cosmetics and toiletries (Journal Officiel 21 April 1973, p. 3862; ibid 5 June 1973, p. 3953) and the methods proposed for the testing of chemicals by the Association Française de Normalisation (AFNOR) and, in 1979, by the Organisation for Economic Co-operation and Development. The results of the three sets of tests were compared and the effects of differences in procedure and numbers of animals were studied, together with the possible relation between irritancy and the pH of the test material.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Roucher SA
- Weight at study initiation: 2.5 kg

Type of coverage:

other: occluded or semi-occluded (OECD)

Preparation of test site:

clipped

Vehicle:

water

Remarks:

: moistened

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours (OECD, AFNOR)
23 hours (French Cosmetic guideline)

Observation period:

1-48 hours (French Cosmetic method)
To Day 14 (AFNOR, OECD)

Number of animals:

3 or 6 (males)

Irritation parameter:

overall irritation score

Basis:

mean

Score:

0.35

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

other: OECD Guideline

Irritation parameter:

overall irritation score

Basis:

mean

Score:

0.54

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

other: French Cosmetic Protocl

Irritation parameter:

overall irritation score

Basis:

mean

Score:

0.36

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

other: ANFOR protocol

Irritant / corrosive response data:

The authors state that the test substance was not irritating when tested according to the OECD protocol. A primary cutaneous irritation index of 0.35 was achieved. The maximum possible score was 8.0. In addition the test substance was also tested according to a protocol for cosmetics which led to a primary cutaneous irritation index of 0.54 (slightly irritant) and according to the AFNOR protocol which led to a primary cutaneous irritation of 0.36 (not irritating).

Other effects:

Not reported

No data

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of this study indicate that aluminium nitrate is a slight skin irritant.

Executive summary:

The skin irritation potential of aluminium nitrate was investigated in the rabbit using three different protocols. The authors state that the test substance was not irritating when tested according to the OECD protocol. A primary cutaneous irritation index of 0.35 was achieved. The maximum possible score was 8.0. In addition the test substance was also tested according to a protocol for cosmetics which led to a primary cutaneous irritation index of 0.54 (slightly irritant) and according to the AFNOR protocol which led to a primary cutaneous irritation of 0.36 (not irritating).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, published in peer reviewed literature, no restrictions, fully adequate for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

equivalent or similar to guideline

Guideline:

other: AFNOR

Qualifier:

according to guideline

Guideline:

other: cosmetics

Principles of method if other than guideline:

the ocular irritation of 56 chemical subsances was investigated by instilling into rabbit's eyes, with or without subsequent rinsing of the treated eyes.
The procedures were standardised to achieve compliance with the pinciples of three differing protocols for determination of eye irritation.
For test substances that elicited more than slight irritation in the initial unrinsed test, a confirmatory test in a further six rabbits was conducted and the eyes were rinsed 30 seconds after dosing. Substances that were irritating is this assay were re-tested in six rabbits with rinsing 4 seconds after dosing

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Roucher SA
- Weight at study initiation: 2.5 kg

ENVIRONMENTAL CONDITIONS
no data

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye acts as inherent control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

single application

Observation period (in vivo):

OECD: 1, 24 and 72 hours. Extended observation if the test article is irritant.
AFNOR: at 1 hour and 1, 2, 3, 4 and 7 days after instillation. Possible extension of observation period to 14 or 21 days to evaluate (ir)reversibility of lesions.
Cosmetics: at 1, 2, 3, 4 and 7 days after instillation.

Number of animals or in vitro replicates:

3-6 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: three different tests were conducted: not rinsed (cosmetic protocol); rinsed after 60 seconds (AFNOR); rinsed after 4 seconds (3 rabbits) and 30 seconds (the other 3 rabbits) (OECD)

SCORING SYSTEM:
Since the Cosmetic and OECD protocols specify no numerical system for the scoring and interpretation of results, a scoring system based on the ANFOR recommendations was used throughout with modifications where appropriate to enable direct comparisons between the protocols to be made.

Irritation parameter:

other: acute/mean ocular irritation index (IOI, day 7)

Basis:

mean

Time point:

other: day 7

Score:

>= 57.83 - <= 60.5

Max. score:

110

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: severe occular irritation persisted at the 7 day reading in eyes that were not washed

Irritation parameter:

other: mean ocular irritation index

Basis:

mean

Time point:

other: Day 7

Score:

32.33

Max. score:

110

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: severe ocular irritation evident in eyes rinsed 30 seconds after instillation

Irritation parameter:

other: mean ocular irritation index

Basis:

mean

Time point:

other: day 7

Score:

15.5

Max. score:

110

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: severe ocular irritation evident in eyes rinsed 4 seconds after instillation

Irritant / corrosive response data:

0.1 g of the test substance was instilled in the lower conjunctival sac of the rabbit eye. Eyes were either not washed out or washed after 4 or 30 seconds. The test substance was juged as irritant if washed out after 4 seconds, as severely irritant if washed out after 30 seconds and as extremely irritant if not washed out. Due to the severity of the results, the test substance has to be judged as posing the risk of serious eye damage (R41) according to EU- and as eye irritant Cat. 1 according to EU CLP-criteria.

The rinsing solution used was Dacryoserum (a solution of boric acid,sodium borate, sodium chloride and phenylmercury borate in distilled water) supplied by Chibet Laboratories, Paris

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Aluminiumnitrate was classified as extremely irritating based on the intial unrinsed assay results - the acute ocular irritation index(AOI) was less than 80 but reversal of effects within 7 days was not achieved. While the effects elicited by aluminium nitrate on the ocular structures was not severe enough to warrant termination of the rabbits on Day 7, the reactions persisted at observations made on Day 14 and 21. Aluminium nitrate was classified as severely irritating in the second test with rinsing after 30 seconds but when the eyes were rinsed within 4 seconds of instillation the reactions were reduced and aluminium nitrate, rinsed out after 4 seconds elicited only slight ocular irritation. The pH of 0.8 recorded for the undiluted substance was considered likely to have contributed to the severity of the ocular effects elicited by aluminium nitrate

Executive summary:

Three protocol procedures were used to compare effects of rinsing on the reduction or reversibility of ocular lesions elicited by 56 substances following instillation rabbits eyes (groups of six or three rabbits were used in each test). Initially six rabbits were treated and the eyes were not rinsed, subtances that elicited greater than slight ocular reactions were re-tested but the eyes were rinsed 30 seconds following instillation. Substances showing irritation in this second protocol were then re-tested but the eyes were rinsed 4 seconds after dosing. Aluminium nitrate elicited severe irritant effects in the first test and reactions persisted to day 21 in the second test, despite some amelioration in the overall severity. Irritation was evident in the third test although rinsing after 4 seconds did result in a reduced response. Classification as severely irritating was indicated by the unrinsed test whereas only slight irritation was observed if treated eyes were rinsed within 4 seconds.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study of dermal irritation in the rabbit assessing the relative skin irritation potential of aluminium nitrate using three different protocols (Guillot et al, 1982) reports that the substance is, at most, a mild skin irritant. The same authors also assessed the eye irritation potential of aluminium nitrate using three different protocols and report severe eye irritation.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available for this endpoint

Justification for selection of eye irritation endpoint:
Only one study available for this endpoint

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The results of the available studies with aluminium nitrate indicate that classification for skin irritation is not required. However classification as a severe eye irritant is indicated (CLP Regulation Category 1 / R41 Dangerous Substances Directive).