Aluminium tri-sec-butanolate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Evaluation of the cutaneous-irritation potential of 56 compounds

Author:

Guillot JP, Gonnet JF, Clement C, Caillard L, Truhaut R

Year:

1982

Bibliographic source:

Food Chem Toxicol 20(5) 563-572

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

under occlusion

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium nitrate

EC Number:

236-751-8

EC Name:

Aluminium nitrate

Cas Number:

13473-90-0

Molecular formula:

Al.3HNO3

IUPAC Name:

aluminum trinitrate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rouché SA, Couhé, France
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet/ water: no data

ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

not specified

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hour (test includes a protocol with 24 hour exposure, but this is not taken into consideration)

Observation period:

upto 14 days (on day 1, 2, 3, 4, 7 and 14)

Number of animals:

6 males/treatment

Details on study design:

TEST SITE
- Area of exposure: 4-6 cm2 (gauge pad moistened with water was applied to the test site)
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : after 1, 24, 48 and 72 hours and on day 7 and 14

SCORING SYSTEM:
- Method of calculation: PCI (not further specified)
- Protocols were based on OECD, AFNOR and Cosmetic regulations, which all have slightly different scoring systems

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks on result:

no indication of irritation

Remarks:

based on OECD and AFNOR protocols

Irritant / corrosive response data:

The PCI was 0.36 and 0.35 for AFNOR and OECD protocols. No details provided.
For the cosmetic protocol with an exposure time of 24 hours under occlusion the substance was found slightly irritating (PCI 0.54)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the skin