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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:
September 29 1982 to January 25 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, carried out according to recognised (older) guideline, results fully documented. Considered appropriate for use based on data available and animal welfare concerns.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Consistent with Environmental Protection Agency's Guidelines for registering pesticides in the U.S.: Hazard evaluation: Humans and Domestic Animals, Fed. Reg. 43:163 37336-37402 (1978); test exceeds the protocol recommended in the OECD Guidelines (1981)
Deviations:
no
Principles of method if other than guideline:
The primary irritation of the skin was measured by a patch-test technique on the abraded and intact skin of six Stauffland albino rabbits. Half a milliliter of the test substance 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 period of four hours. After 4 hours of exposure, the patches and test material were removed, and the resulting reactions were given a score. Readings were also made after 24 and 72 hours and the final score represents an avaerage of all the readings. The scoring and evaluation criteria are those described by Draize (1965).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fyrquel EHC (Trixylenyl phosphate)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: not specified
- Physical state: liquid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: #9221-J-1-1X
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals

Species:
rabbit
Strain:
other: Stauffland albino
Details on test animals and environmental conditions:
Animals used for this study were purchased from Phillips Rabbitry, Soquel, California.
No details on environmental conditions are provided.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
The primary irritation of the skin was measured by a patch-test technique on the abraded and intact skin of six Stauffland albino rabbits. Half a milliliter of the test substance 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 period of four hours. After 4 hours of exposure, the patches and test material were removed, and the resulting reactions were given a score. Readings were also made after 24 and 72 hours and the final score represents an avaerage of all the readings. The scoring and evaluation criteria are those described by Draize (1965).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
72 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: score attributed to erythema / eschar presence
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: score attributed to erythema / eschar presence
Irritant / corrosive response data:
Fyrquel EHC Trixylenyl phosphate produced mild erythema in intact and abraded skin of 6 rabbits following 4 hour exposure. By the 24 hour observation irritation decreased in 2 rabbits. At 72 hours irritation had cleared in 4 rabbits and 2 rabbits had mild erythema.
Other effects:
None noted

Any other information on results incl. tables

Results

 

Skin type

Erythema-eschar

Observation

Edema

Observation

Sum

Total

Score*

Rabbit No

 

 

4 hr.

24 hr.

72 hr.

4 hr.

24 hr.

72 hr.

83-F-l

Intact

1

0

0

0

0

0

3.0

0.50

 

 

 

 

 

 

 

Abraded

1

1

0

0

0

0

 

 

 

 

 

 

 

 

 

 

83-F-2

Intact

1

1

0

0

0

0

4.0

0.67

 

 

 

 

 

 

 

Abraded

1

1

0

0

0

0

 

 

 

 

 

 

 

 

 

 

83-F-3

Intact

1

0

0

0

0

0

2.0

0.33

 

 

 

 

 

 

 

Abraded

1

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

83-F-4

Intact

1

1

0

0

0

0

4.0

0.67

 

 

 

 

 

 

 

Abraded

1

1

0

0

0

0

 

 

 

 

 

 

 

 

 

 

83-F-5

Intact

1

1

1

0

0

0

6.0

1.0

 

 

 

 

 

 

 

Abraded

1

1

1

0

0

0

 

 

 

 

 

 

 

 

 

 

83-F-6

Intact

1

1

1

0

0

0

6.0

1.0

 

 

 

 

 

 

 

Abraded

1

1

1

0

0

0

Primary Irritant Score

 

0.70

*Score = Sum of individual values for each rabbit divided by six.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Fyrquel EHC (Trixylenyl phosphate) was a mild irritant to intact and abraded skin of albino rabbits after a 4 hour exposure. This formulation produced mild erythema in intact and abraded skin of 6 rabbits following 4 hour exposure. By the 24 hour observation irritation decreased in 2 rabbits. At 72 hours irritation had cleared in 4 rabbits and 2 rabbits had mild erythema.
Executive summary:

Fyrquel EHC (Trixylenyl phosphate) was a mild irritant to intact and abraded skin of albino rabbits after a 4 hour exposure. This formulation produced mild erythema in intact and abraded skin of 6 rabbits following 4 hour exposure. By the 24 hour observation irritation decreased in 2 rabbits. At 72 hours irritation had cleared in 4 rabbits and 2 rabbits had mild erythema.

On the basis of EU Criteria, the substance is not classified as a skin irritant.