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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
3rd September 1985 to 6th September 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study is conducted by recognised test house, to experimental procedure in compliance with OECD Guideline 402 and Annex V of the 6th Amendment of the EEC Directive 79/831/EEC - Part B: Methods for the determination of toxicity B4 Skin Irritation. Full data set and rationale provided. GLP compliance not specified, although report is subject to Quality Assurance Procedure.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
and method B4, Annex V 79/831/EEC
Deviations:
no
GLP compliance:
not specified
Remarks:
No mention of GLP is made within the report; however the report was subject to Quality Assurance at the laboratory where the testing was conducted. As such, it is assumed that the principles of GLP were followed

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Bontron E-84
- Substance type: Solid
- Physical state: White powder
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not determined
- Lot/batch No.: No batch number is specified within the report, but the test substance is deemed equivalent based on history of manufacture and use.
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperatures

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Rabbits, Petersfield, Hampshire, England
- Age at study initiation: Approximately 9 to 10 weeks
- Weight at study initiation: 1.9 to 2.2 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Standard Rabbit diet ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: Exact period not specified, although stated that the rabbits selected for the study were all acclimated to the laboratory environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.

IN-LIFE DATES: From: 3rd September 1985 To: 6th September 1985

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g was applied under a 2.5 cm square gauze pad moistened with 0.5 ml distilled water to one intact skin site on each animal
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar region, approximately 10cm square.
- % coverage: Not specified.
- Type of wrap if used: Occluded with "Elastoplast" elastic adhesive dressing for a 4 hour period


REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Examination of the treated skin sites was made on Day 1 (approximately 30 minutes after removal of the treatment patches) and days 2, 3 and 4.
Grading and scoring of the dermal reactions were performed using the standard prescribed numerical scoring system for evaluating as follows:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptable): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Oedema Formation:
No oedema: 0
Very slight oedema (barely perceptable): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4

Any other lesions not covered by the above were to be described within the study report.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
0
Basis:
mean
Time point:
other: 96 hours
Score:
0
Max. score:
0
Remarks on result:
other: No response to the treatment was noted in any animal
Irritant / corrosive response data:
None of the animals showed any observable response to treatment throughout the four days observation period.
Other effects:
None

Any other information on results incl. tables

Rabbit Number and Sex

E = Eyrthema

O = OEdema

Day

1*

2

3

4

558F

E

O

0

0

0

0

0

0

0

0

559M

E

O

0

0

0

0

0

0

0

0

571F

E

O

0

0

0

0

0

0

0

0

* Approximately 30 minutes after removal of the dressing.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects were noted on the skin of the animals tested during the study period. Hence, it is deemed that the substance is not classified for irritation to the skin.
Executive summary:

The dermal irritation of the substance was tested in vivo with three New Zealand White rabbits. Using a semi-occluded dressing, no reaction were noted during the study. The substance was concluded to be non-irritating.