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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:
key study
Study period:
29/06/1981 - 08/09/1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study according to EPA Guideline (Fed. Reg. 43:163, 37336-37402, 1978). QA. Diet and environmental conditions not reported. Acceptable basic data.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA Guideline for registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals, Fed. Reg. 43:163, 37336-37402, 1978.
Deviations:
yes
Remarks:
Exposure time: 24 hours
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phosflex 72B
- Physical state: Liquid
- Composition of test material, percentage of components: confidential
- Lot/batch No.: confidential

Test animals

Species:
rabbit
Strain:
other: Stauffland albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California, USA

ENVIRONMENTAL CONDITIONS: No data

IN-LIFE DATES: No data

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted (100%)
Duration of treatment / exposure:
24 hours
Observation period:
After 24 and 72 hours of exposure
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: No data
- % coverage: No data ( one-inch square gauze patch)
- Type of wrap if used: The patches were secured in place by adhesive tape and wrapped with rubberized damming for the 24-hour period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: Removal after 24 hours

SCORING SYSTEM: The scoring criteria as described by Draize (Draize, J. H. (1965). Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics - Dermal Toxicity, Assoc. of Food and Drug Officials of the U.S. Topeka, Kansas, pp. 49-52). Erythema and Eschar formation / Oedema formation. Primary Irritation Index scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: no 14 days observation period done for reversibility
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Intact and abraded skin
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Intact and abraded skin
Time point:
24 h
Score:
0.5
Max. score:
0.5
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
24 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact and abraded skin
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other:
Remarks:
no 14 days observation period done for reversibility
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0.5
Max. score:
0
Reversibility:
fully reversible within: 72hours
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact and abraded skin
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
other: No measurements after 48 hours
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
No measurments after 48 hours
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Phosflex 72B produced mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of albino rabbits following a 24 hour exposure. At the 72 hour observation, irritation decreased and included mild erythema in one of the six rabbits (no 14 days observation period done for reversibility).
Other effects:
None

Any other information on results incl. tables

Primary Irritant Score = 0.46

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Phosflex 72B produced mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of albino rabbits following a 24 hour exposure. At the 72 hour observation, irritation decreased and included mild erythema in one of the six rabbits (no 14 days observation period done for reversibility). Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

The primary irritation of the skin was measured by a patch-test technique on the abraded and intact skin of six Stauffland albino rabbits, according to EPA Guideline Fed. Reg. 43:163, 37336-37402, 1978. 0.5 ml of the test substance (Phosflex 72B) was introduced under a one-inch square gauze patch. The patches were secured in place by adhesive tape and wrapped with rubberized damming for a 24 hour period. After 24 hours of exposure, the patches and test material were removed, and the resulting reactions were given a score. Readings were made after 24 and 72 hours, and the final score represents an average of all readings. The scoring and evaluation criteria are those described by Draize (1965).

Phosflex 72B produced mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of albino rabbits following a 24 hour exposure. At the 72 hour observation, irritation decreased and included mild erythema in one of the six rabbits (no 14 days observation period done for reversibility). Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for skin irritation.