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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, conducted according to OECD guideline no 406.
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:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
none
GLP compliance:
yes
Type of study:
other: footpad
Justification for non-LLNA method:
Study was conducted prior to LLNA being mandated

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical Name: 2-Propoxyethanol
EK Accession No.: 907124
HAEL Laboratory No.: 88-0017
SRID or Lot I.D. No.: T62-15 (1-19-88)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, MA, USA
- Age at study initiation:
Irritation - Approximately 9 weeks old.
Induction - Approximately 6 weeks old.

- Weight at study initiation:
Body Weight Range at Dasing (g): Irritation - 475 - 556
Induction - 347 - 495
- Housing: All animals were indiv:Ldually housed in suspended stainless steel mesh cages.

- Diet (e.g. ad libitum) and water: Agway prolabm Guinea pig Diet certified pellets, and water, obtained from the Monroe County (NY) Water Authority, were provided libitum. No known contaminants which would interfere with the outcome of the study were expected to be present in feed or water from these sources. Analyses of feed and results of quarter1.y analyses of water are maintained on file within the testing laboratory.

- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature : 70-74' F
- Humidity (%): 46-50

- Photoperiod (hrs dark / hrs light):A photoperiod of 12 hours from 6 a.m. to 6 p.m. was maintained.


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 1% solution of the test compound in a mixture of acetone, dioxane, and guinea pig fat (7:2:1)
Concentration / amount:
0.05 mL of Freund's containing 1% test compound.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: 1% solution of the test compound in a mixture of acetone, dioxane, and guinea pig fat (7:2:1)
Concentration / amount:
0.05 mL of Freund's containing 1% test compound.
No. of animals per dose:
10 animals were injected with 0.05 mL of Freund's containing 1% test compound.
Details on study design:


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period: 7 days
- Site: backs of the animals
- Concentrations: with 0.05 mL of Freund's containing 1% test compoun


B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 24 hours
- Exposure period: 24 hours
- Test groups: single group with 10 animals
- Control group: single group with 10 animals
- Site: backs of the animals
- Concentrations: solution of test material (at the concentration determined in the previous step) in acetone, dioxane, and guinea pig fat (7:2:1).
- Evaluation (hr after challenge): at 24 and 48 hours

Challenge controls:
Freund's Complete Adjuvant Only
single group of 10 animals
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Vehicle:
other: not applicable
Concentration:
not applicable
No. of animals per dose:
not applicable
Details on study design:
not applicable
Positive control substance(s):
other: not applicable
Statistics:
not applicable

Results and discussion

Positive control results:
none

In vivo (non-LLNA)

Results
Reading:
other: unknown
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not applicable

Any other information on results incl. tables

see the attached word doc for tables and figures:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test material did not cause a sensitization response when tested by this method .
Executive summary:

Skin sensitization test was conducted by foot pad method using Guinea pigs. 2 groups of 10 animals were used in sensitization study.

All animals were individually housed in suspended stainless steel mesh cages. A photoperiod of 12 hours from 6 a.m. to 6 p.m. was maintained. Room temperature was maintained at 70-74' F, relative humidity was maintained at 46-50%.

Agway prolabm Guinea pig Diet certified pellets, and water, obtained from the Monroe County (NY) Water Authority, were provided libitum. No known contaminants which would interfere with the outcome of the study were expected to be present in feed or water from these sources. Analyses of feed and results of quarterly analyses of water are maintained on file within the

testing laboratory. Guinea pigs were isolated and monitored for at least 5 days after arrival before release to the testing facility.

Ten animals were injected in the footpad with 0.05 mL of Freund's complete adjuvant. At the same time, 10 other animals were injected in the same manner with 0.05 mL of Freund's containing 1% test compound. Seven days later the hair was removed from the backs of the animals with an electric clipper. The animals were then challenged with a solution of test material (at the concentration determined in the previous step) in acetone, dioxane, and guinea pig fat (7:2:1). The animals were depilated 24 hours after the challenge dose and the reaction to the topical challenge was scored. The next day (48 hours after challenge) the reaction was scored again. Ten animals were injected in the footpad with 0.05 mL of Freund's complete adjuvant. At the same time, 10 other animals were injected in the same manner with 0.05 mL of Freund's containing 1% test compound. Seven days later the hair was removed from t.he backs of the animals with an electric clipper. The animals were then challenged with a solution of test material (at the concentration determined in the previous step) in acetone, dioxane, and guinea pig fat (7:2:1). The animals were depilated 24 hours after the challenge dose and the reaction to the topical challenge was scored. The next day (48 hours after challenge) the reaction was scored again.

At both observation times, the challenged skin areas were graded for erythema and edema using numerical ratings as follows:

Erythema                             Edema

0 - none 0 - none

1 - just discernible - slight                            1 - just discernible to touch - slight

2 - easily determined - moderate                      2 - easily determined - moderate

3 - dark red-strong                             3 - difficult to pick up a fold of skin - strong

Body weights were collected on the day of footpad injection and again after challenge. All animals previously induced with Freund's adjuvant or the test material in Freundls adjuvant gained weight normally.

Animals were not necropsied at the conclusion of the test.

Based on the results of the study the test material did not cause a sensitization response when tested by this method