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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 September 2005 and 09 september 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
It is a legal and ethical duty under the Animals (Scientific Procedure) Act 1986 that, in the interest of animal welfare, the unnecessary use of animals is avoided, and that any testing which is likely to produce severe responses in animals is minimised.

Therefore, before in vivo irritation testing is performed, all existing information on the test material, or its analogues should be reviewed. In the absence of any readily available literature or client information regarding the irritation potential of the test material, a Trancutaneous Electrical Resistance Assay (TER) was performed.

This step-wise procedure is in accordance with OECD Test Guideline 404, UK Home Office regulations and SafePharm Laboratories Limited ethical testing strategy.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
B&K Universal Ltd, Hull, UK.

- Age at study initiation:
28 - 30 days old.

IN-LIFE DATES: From: 08 Sept 05 To: 09 Sept 05

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
A volume of 150 micro L was applied.

- Concentration (if solution):
The test material was used as supplied.

VEHICLE
No vehicle used
Duration of treatment / exposure:
24 hours
Observation period:
24 hours
Number of animals:
2 generated three skin discs used for the study
Details on study design:
TEST SITE
- Area of exposure:
The test material was applied to the epidermal surface of three skin discs for a contact period of 24 hours.

- % coverage:
Not recorded

- Type of wrap if used:
None used

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
The test material was removed by washing the skin disc with a jet of warm tap water for approximately 10 seconds until no further test material could be removed.

- Time after start of exposure:
Not recorded.

SCORING SYSTEM:
If the positive and negative control results for the assy do not fall within the accepted ranges, the data on the test substance cannot be interpreted as being reliable, and the experiment must be repeated.

Hydrochloric acid(approximately 36%), Positive control range: 0.5 to 1.0 k
Sterile distilled water, Negative control range: 10 to 25 k

The test substance will be classified as 'Non-corrosive' if the mean TER value recorded for the 24 hour contact period is greater than 5 k.

The test substance will be classified as 'corrosive' if the mean TER value recorded for the 24 contact period is 5k or lower.

Results and discussion

In vivo

Results
Remarks on result:
other: Potential to cause corrosion in vivo

Any other information on results incl. tables

Results

Individual and mean Transcutaneous Electrical Resistance (TER) measurements are given in Table 1: see attached document Mean TER Test material.

The mean TER recorded for the 24 hour test matrial contact period was less than 5k.

Individual and mean Transcutaneous Electrical Resistance (TER) measurements for the positive and negative controls are given in table 2 and table 3. Please see attached documents.

The TER recorded for the positive and negative control discs were as follows:

Hydrochloric acid (aprroximately 36%), Positve control disc: 785.7k

The results are summarised as follows:

Test Material Contact Period Mean Electrical Resistance (Standard Deviation)
24 hours 2.0 kΏ (+/- 0.66)

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Following assessment of the data the test material was considered to have the potential to cause corrosion in vivo. The in vivo skin irritation study is therefore not required.