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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 July 2012 - 2 August 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Skin Irritation (2-1-4), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium hexatitanate
EC Number:
815-182-4
Cas Number:
12058-75-2
Molecular formula:
Na2Ti6O13
IUPAC Name:
Disodium hexatitanate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Description: White powder
Storage conditions: Room temperature
Batch number: 1C96
Date of receipt: 26 August 2011
Expiry date: 24 March 2014
Purity: 100%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
They were in the weight range of 3.36 to 4.27 kg and 36 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment for a period of 11 to 18 weeks prior to the start of the study. The rabbits were housed individually in plastic cages with perforated floors. Each rabbit was offered 125 g of a standard laboratory rabbit diet per day; drinking water was provided ad libitum. The batch of diet used for the study was analysed for nutrients, possible contaminants and micro-organisms likely to be present in the diet and which, if in excess of specified amounts, might have an undesirable effect on the test system. The animals were given a dietary supplement of hay. During the acclimatisation and study period the animals were given small soft white untreated wood blocks for environmental enrichment. Results of routine physical and chemical examination of drinking water, as conducted by the supplier are made available to Huntingdon Life Sciences Limited. Animal room environmental controls were set to maintain temperature within the range 16 to 20°C, and relative humidity within 40 to 70%. These environmental parameters were recorded and the permanent record archived with other departmental raw data. Lighting was
controlled by means of a time switch to give 12 hours of artificial light (06:00 to 18:00 GMT) in each 24 hour period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
The treatment site was ‘wetted’ with 0.5mL of reverse osmosis water and approximately 0.5 g of the test substance was applied
Duration of treatment / exposure:
A single animal (number 150) received three exposures of three minutes, one or four hours duration in a step-wise manner and acted as a preliminary screen. In the absence of a severe effect on removal of the dressings the next exposure was initiated. In the absence of a severe effect in this animal, a further two animals were committed to the study.
Observation period:
Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and approximately 1, 24, 48 and 72 hours later. Only the data for the four hour exposure are reported, the data from the three minute and one hour exposures are held in the archives.
Number of animals:
A single animal (number 150) received three exposures of three minutes, one or four hours duration in a step-wise manner and acted as a preliminary screen. In the absence of a severe effect on removal of the dressings the next exposure was initiated. In the absence of a severe effect in this animal, a further two animals were committed to the study.
Details on study design:
At the end of the exposure period the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Remarks on result:
no indication of irritation
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.
No dermal reaction was observed in any animal throughout the duration of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Primary Irritation Index was calculated to be 0.0; test substance was classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008.