Registration Dossier

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:
Not reported. Test material was received 12 July 1977, study report was finalised 7 December 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was applied to 6 rabbits with intact (3) and abraded skin (3). The test substance was removed after 4 hours and the sites washed with tepid water. Skin irritation was assessed 1, 24, 48 and 72 hours following removal of the test substsance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material identified as 'Firemaster 100 Lot 53 77.902' and was received as a fine white powder.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Kuiper's Rabbit Ranch, Gary, Indiana.

- Age at study initiation:
Not reported.

- Weight at study initiation:
2080-2210 grams

- Housing:
The animals were individually housed in metal metabolism cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum):
Purina Rabbit Chow were available ad libitum.

- Water (e.g. ad libitum):
ad libitum

- Acclimation period:
Not reported.

ENVIRONMENTAL CONDITIONS
The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals".



IN-LIFE DATES: From: Day 1 To: Day 3

Test system

Type of coverage:
occlusive
Preparation of test site:
other: all animals had test site shaved, 3 animals had test site abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
500 mg

- Concentration (if solution):
Not reported.

VEHICLE
- Amount(s) applied (volume or weight with unit):
Not reported.

- Concentration (if solution):
0.9%

- Lot/batch no. (if required):
Not reported.

- Purity:
Not reported.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
- Area of exposure:
Back part of each rabbit.

- % coverage:
20-30% of body surface

- Type of wrap if used:
The application sites were covered with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Yes, sites were washed with tepid tap water.

- Time after start of exposure:
4 hours.

SCORING SYSTEM:
-Erythema and Eschar Formation: Value.
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight
eschar formation (injuries in depth): 4

Edema Formation:
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by
definite raising): 2
Moderate edema (raising approximately
1.0 mm): 3
Severe edema (raised more than 1.0 mm
extending beyond the area of exposure): 4

Mean Primary Irritation Score
Range of Values Descriptive Rating
0 Non-Irritating
0.1 - 0.5 Minimally Irritating
0.6 - 1.5 Slightly Irritating
1.6 - 3.0 Mildly Irritating
3.1 - 5.0 Moderately Irritating
5.1 - 6.5 Severely Irritating
6.6 - 8.0 Extremely Irritating



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for animals with intact skin.
Time point:
other: 24 hours
Score:
0.33
Max. score:
0.5
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for animals witn intact skin
Time point:
other: 48 hours
Score:
0.16
Max. score:
0.5
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
for animals with intact skin
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: an edema score of 0 was reported for all observation times.
Irritant / corrosive response data:
Erythema:
2 animals in the intact skin group showed some slight Erythema (score of 0.5 each) at the 24 observation. 1 of these animals showed the same level of erythema (0.5) at the 48 hour observation. All animals with intact skin showed no Erythema at the 72 hour observation.
No animals with abraded skin showed any Erythema during the observation period.

Edema:
No animals with intact skin showed any Edema during the observation period.
No animals with abraded skin showed any Edema during the observation period.
Other effects:
None reported.

Any other information on results incl. tables

Erythema/Edema scores per animal (intact skin):

Animal No./Sex Erythema Edema
Observation Period (hours) Observation Period (hours)
4 24 48 72 4 24 48 72
28929, Male 0 0 0 0 0 0 0 0
28934, Female 0.5 0.5 0.5 0 0 0 0 0
28936, Female 0 0.5 0 0 0 0 0 0

Erythema/Edema scores per animal (abraded skin):

Animal No./Sex Erythema Edema
Observation Period (hours) Observation Period (hours)
4 24 48 72 4 24 48 72
28930. Female 0 0 0 0 0 0 0 0
28933, Male 0 0 0 0 0 0 0 0
28937. Male 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the irritation scores obtained the registered substance does not meet the criteria for classification set out in 67/458/EEC.
Executive summary:

Three male and 3 female New Zealand White rabbits were used for this study.

The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded by making shallow incisions with a scalpel blade, not sufficiently deep to cause bleeding.

500 mg of the test material was applied to the back of each rabbit using 0.9% Physiological Saline as a wetting agent. The application sites were then covered with gauze bandaging and occluded with Saran Wrap. Four hours later the bandages were re­moved and the sites were washed with tepid tap water and examined for skin irritation. These examinations were repeated at 24, 48 and 72 hours.

Based upon the irritation scores obtained the registered substance does not meet the criteria for classification set out in 67/458/EEC.