Petrolatum (petroleum), oxidized, calcium salt

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-10-13 to 1994-11-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction since it was conducted according to the EPA Guideline 81-6 (skin sensitisation) which is equivalent or similar to OECD Guideline 406.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-6 (Skin Sensitisation)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

Not avaliable at that time

Test material

Test material information

Constituent 1

Reference substance name:

White Petrolatum USP (CAS # 8009-03-8) (For Petrolatum (Non-carcinogenic Feed-stock))

IUPAC Name:

White Petrolatum USP (CAS # 8009-03-8) (For Petrolatum (Non-carcinogenic Feed-stock))

Details on test material:

- Name of test material (as cited in study report): 4531 Pet Blend White USP
- Substance type: Sufficiently Refined Petrolatum
- Physical state: Paste
- Analytical purity: 100%
- Lot/batch No.: 4531 25* 93 W9414
- Storage condition of test material: room temperature
- Other: pale yellow paste

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: SASCO, Inc. (Madison, Wisconsin)
- Age at study initiation: Not reported
- Weight at study initiation: Males (347-388 g); Females (324-407 g)
- Housing: 1 to 4 animals (males and females separate) in suspended, wire bottom, stainless steel cages
- Diet (e.g. ad libitum): Purina Guinea Pig Chow; available ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: 1994-09-27 To: 1994-11-16

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

400 mg (undiluted) for induction and challenge phase

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

400 mg (undiluted) for induction and challenge phase

No. of animals per dose:

2/sex/dose (Screening Test)
5/sex/dose (Dermal Sensitization Study)

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours per exposure
- Test groups: 400 mg undiluted petrolatum
- Control group: 1.0 % w/v 1-chloro-2,4-dinitrobenzene (DNCB) in ethanol
- Site: Left front quadrant of back
- Frequency of applications: 1 per week
- Duration: 6 hours


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks post last inducation exposure
- Test groups: 400 mg undiluted petrolatum
- Control group: 0.15% w/v 1-chloro-2,4-dinitrobenzene (DNCB) in ethanol
- Site: Right rear quadrant of back
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:

10 animals

Positive control substance(s):

yes

Remarks:

1-chloro-2,4-dinitrobenzene (DNCB)

Results and discussion

Positive control results:

All animals in the positive control group exhibited skin irritation scores at the 24 and 48 hours observations post challenge. The average skin reaction scores were 1.5 and 1.9 (24 and 48 hours post challenge, respectively).

In vivo (non-LLNA)

Results

Results 1

Reading:

other: challenge

Hours after challenge:

24

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other: challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 2

Reading:

other: Challenge

Hours after challenge:

24

Group:

test chemical

Dose level:

400 mg

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 400 mg. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 3

Reading:

other: Challenge

Hours after challenge:

24

Group:

positive control

Dose level:

0.15% w/v DNCB in ethanol

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

Average skin reaction scores were 1.5 and 1.9 (24 and 48 hours post challenge, respectively)

Remarks on result:

other: see Remark

Remarks:

Reading: other: Challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.15% w/v DNCB in ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average skin reaction scores were 1.5 and 1.9 (24 and 48 hours post challenge, respectively).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

White petrolatum when applied undiluted was not observed to be a dermal sensitizer in male and female guinea pigs.

Executive summary:

In a dermal sensitization study using white petrolatum USP (CAS No. 8009-03-8), young adult Hartley (albino) guinea pigs (5/sex) were tested using a modified Beuhler method in a guinea pig dermal sensitisation assay.

 

The test material, 4531 Pet Blend White USP, produced no irritation in animals of the naive control group after the single treatment at challenge. The test material likewise produced no irritation in animals of the test group after the challenge treatment and therefore did not elicit a sensitizing reaction in guinea pigs.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction since it was conducted according to the EPA Guideline 81-6 (skin sensitisation) which is equivalent or similar to OECD Guideline 406.