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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:
Between 1984/05/23 and 1984/06/01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline N°404 but not in compliance with GLP.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Between 1984/05/23 and 1984/06/01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline N°404 but not in compliance with GLP.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Guideline study
GLP compliance:
no
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0.67 - <= 2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 1.33
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
See Table I, the test substance is slightly irritating:
- Very slight reactions were seen in two animals during the 4 days observation period. The skin of both animals was normal on day 4
- Very slight erythema was seen in the third animal following removal of the bandage. By day 2, well defined erythema with slight oedema had developed and persisted to day 8. The skin was normal on day 10.
Other effects:
None

Table 5.2.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

24 h

1/1/2

0/0/0

48 h

1/1/2

0/1/2

72 h

0/0/2

0/1/2

Average 24h, 48h, 72h

0.67-0.67 -2

0-0.67 -1.33

Reversibility*

c

c

Average time (unit) for reversion

within day 10

within day 10

C: completely reversible

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Petrepar-147 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
Executive summary:

This data is being read across from the source study that tested Hydrocarbons, C14-C17, n-alkanes, <2% aromatics based on analogue read across.

In a primary dermal irritation study conducted according to OECD 404 without compliance in GLP, three rabbits were exposed to 0.5 mL of Petrepar-147. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 10 days. The skin reactions were assessed at 1, 24, 48 and 72 hours, as well as 5 and 10 days after removal of the dressing. The mean score was calculated across 3 scoring times; 24, 48 and 72 hours after patch removal, for each animal separately.

The mean individual scores were 0.67, 0.67, 2.0 for erythema and 0.00, 0.67, 1.33 for edema. Skin reactions were totally reversible at day 10. Petrepar-147 is slightly irritating.

Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, Petrepar-147 is not considered as irritating to the rabbit skin.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Guideline study
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
EC Number:
917-828-1
Molecular formula:
none available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
Constituent 2
Reference substance name:
Petrepar 147 (P-147)
IUPAC Name:
Petrepar 147 (P-147)
Details on test material:
- Name of test material (as cited in study report): Petrepar 147 (P-147)
- Substance type: petroleum product, UVCB
- Physical state: colourless liquid
- Analytical purity: 100 % commercial product
- Composition of test material, percentage of components: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill Ltd. Huntingdon; Cambridgeshire
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.1-2.3kg
- Housing: individually
- Diet (e.g. ad libitum): SDS, standard rabbit diet
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70 %
- Air changes (per hr): 19 times/hour
- Photoperiod (hrs dark / hrs light): 12 h/ 12h


IN-LIFE DATES: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Electric clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, undiluted
Duration of treatment / exposure:
4 hours
Observation period:
Skin reaction assessed at 1, 24, 48 and 72 hours, and 5, 10 days after exposure (after the removal of the patch)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square gauze pads
- % coverage: no data
- Type of wrap if used: Each treatment site was occluded with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment site was washed using distilled water to remove any residual test substance
- Time after start of exposure: just after 4 hours exposure


SCORING SYSTEM: in accordance with the OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0.67 - <= 2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 1.33
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
See Table I, the test substance is slightly irritating:
- Very slight reactions were seen in two animals during the 4 days observation period. The skin of both animals was normal on day 4
- Very slight erythema was seen in the third animal following removal of the bandage. By day 2, well defined erythema with slight oedema had developed and persisted to day 8. The skin was normal on day 10.
Other effects:
None

Any other information on results incl. tables

Table 5.2.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

24 h

1/1/2

0/0/0

48 h

1/1/2

0/1/2

72 h

0/0/2

0/1/2

Average 24h, 48h, 72h

0.67-0.67 -2

0-0.67 -1.33

Reversibility*

c

c

Average time (unit) for reversion

within day 10

within day 10

C: completely reversible

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Petrepar-147 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
Executive summary:

In a primary dermal irritation study conducted according to OECD 404 without compliance in GLP, three rabbits were exposed to 0.5 mL of Petrepar-147. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 10 days. The skin reactions were assessed at 1, 24, 48 and 72 hours, as well as 5 and 10 days after removal of the dressing. The mean score was calculated across 3 scoring times; 24, 48 and 72 hours after patch removal, for each animal separately.

The mean individual scores were 0.67, 0.67, 2.0 for erythema and 0.00, 0.67, 1.33 for edema. Skin reactions were totally reversible at day 10. Petrepar-147 is slightly irritating.

Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, Petrepar-147 is not considered as irritating to the rabbit skin.