reaction product of alumina and sulfuric acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-08-30 - 2017-09-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Remarks:

certified by Slovak National Acreditation Service, Karloeská 63, 840 00 Bratislava 4, Slovak Republic

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

reaction product of alumina and sulfuric acid

EC Number:

812-508-7

Cas Number:

1093112-19-6

Molecular formula:

unspecified, UVCB substance

IUPAC Name:

reaction product of alumina and sulfuric acid

Test material form:

solid: particulate/powder

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

male

Details on test animals and environmental conditions:

Source: AnLab Prague (Czech Republic), 29 females (non-pregnant, nulliparous), 6 days acclimated, 10 weeks old at first dose, healthy,
housing, diet, water, bedding according guideline, animal identification by marking with a permanent penn on the tail,
The study was approved by State Veterinary and Food Administration of SR according to national requrements for the protection of animals

Study design: in vivo (LLNA)

Vehicle:

other: The vehicle (Acetone:Olive Oil, 4:1, v/v) was selected from the recommended vehicles according to OECD Guideline No. 429. The test item was not soluble in the vehicle; therefore a homogeneous suspension was obtained.

Concentration:

The doses were selected from the concentration series 100%, 50%, 25%, 10%, 5%, 2.5% etc. according to OECD Guideline No. 429.
The starting concentration was determined according to pre-screen test result.

No. of animals per dose:

5 females – negative control (vehicle)
5 females – positive control
15 females – test item
4 females - pre-screen test plus spare animals

Details on study design:

Pre-screen test
The test item was administered in two mice at concentration of 25%. After the test item application, no signs of local irritation at the application site or systemic toxicity were observed.

Main Study
Based on the observations recorded in the preliminary test, the concentration of 25, 10 and 5% was selected for the main test.
Clinical Observations
Animals were carefully observed for any clinical symptoms, either of local irritation at the application site or systemic toxicity. The daily clinical observation of the animals did not show visible clinical signs.
Body Weights
The animal body weights were measured prior to the first treatment and at the scheduled sacrifice. A minor increase of body weight was observed at all used concentrations. The increase was not statistically significant.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

pooled treatment group approach, no statistics for SI

Results and discussion

Positive control results:

SI = 6.79
Calculated with corresponding control (value of 1423 DPM)

In vivo (LLNA)

Results

Key result

Parameter:

SI

Value:

>= 0.91 - <= 1.16

Variability:

0.95 - 0.91 -1.19

Test group / Remarks:

main study: 5 test groups: Negative control (vehicle), positive control, test substance: 5%, 10%, 25%, dose-dependent lymph node weights and DPM values

Remarks on result:

other: all SI < 3, therefore not sensitizing in this test

Cellular proliferation data / Observations:

pre-screening test: no clinical signs
main study: no clinical signs observed, dose-dependant increase in pooled lymph node weights and DPM values, SI (except positive control group) under the threshold of 3, therefore not sensitizng in this test

Any other information on results incl. tables

A concentration of 25% was used as the highest dose in the pre-screen test, as this was the highest achievable concentration.

In the Main study, the test item was applied over three consecutive days, at the three concentrations 5, 10 and 25% suspended in Acetone:Olive Oil 4:1. All animals survived throughout the test period without showing any clinical signs. A minimal difference between control group and animal treated groups in pooled lymph node weights was observed. A similar trend was registered in the evaluation of DPM of the lymph nodes. Calculated SI values in treated groups remained under the value of 3, which

is the threshold to consider the substance a sensitizer. Therefore, it was not possible to calculate an EC3 value.

These results demonstrate that Sulfuric acid, reaction product with alumina is a not potential skin sensitizer under the test conditions of this study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, Sulfuric acid, reaction product with alumina is not considered a skin sensitizer under the condition of this LLNA study.