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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:
From 30th of April to 3rd of May 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Method similar as OECD guideline N°404 in compliance with GLP. Six rabbits were treated. Substance identification: code name with commercial substance name. Substance analytical certificate not available in the report
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:
From 30th of April to 3rd of May 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Method similar as OECD guideline N°404 in compliance with GLP. Six rabbits were treated. Substance identification: code name with commercial substance name. Substance analytical certificate not available in the report
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
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No animal death prior to study termination.
Topical application of MRD-90-903 elicited no responses in any animal.
Other effects:
No additional data.

Table 7.3.1/1: 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

0/0/0/0/0/0

0/0/0/0/0/0

48 h

0/0/0/0/0/0

0/0/0/0/0/0

72 h

0/0/0/0/0/0

0/0/0/0/0/0

Average 24h, 48h, 72h

0.0

0.0

Reversibility*

-

-

Average time (unit) for reversion

-

-

*Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, MRD-90-903 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, C16-C20, n-alkanes, isoalkanes, cyclics, < 2% aromatics based on analogue read across.

In a primary dermal irritation study conducted as similar to OECD guideline N°404 in compliance with GLP, six young adult female New Zealand White rabbits were dermally exposed to 0.5 mL of MRD-90-903. Test sites were covered with a semi-occlusive dressing for 4 hours. The skin reactions were assessed at 45 minutes, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times for all animals at 24, 48 and 72 hours after patch removal.

The mean scores over 24, 48 and 72 hours were 0.0 for erythema and for oedema.

Based upon the directive 67 /548/EEC and the CLP Regulation 1272/2008, MRD-90-903 is not considered as irritating to the rabbit skin.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
One rabbit was sacrificed by cardiac puncture. The authors considered this deviation is not pertinent.
Principles of method if other than guideline:
Guideline principles
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, <2% aromatics
EC Number:
919-029-3
Molecular formula:
Combination of mainly CnH2n+2 and CnH2n structures, comprised mainly within a carbon number range from C16 to C20
IUPAC Name:
Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, <2% aromatics
Constituent 2
Reference substance name:
Exxsol D140
IUPAC Name:
Exxsol D140
Constituent 3
Reference substance name:
MRD-90-903
IUPAC Name:
MRD-90-903
Details on test material:
- Name of test material (as cited in study report): MRD-90-903
- Substance type: petroleum product, UVCB
- Physical state: colorless liquid
- Analytical purity: 100% Commercial product
- Lot/batch No.: I
- Storage condition of test material: room temperature
- Other: pH=6

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 1.85 to 2.29 kg
- Housing: individual
- Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit, restricted feeding regimen
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): from 65 to 70°F
- Humidity (%): maintained range of 40 to 60% relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): approximately 12 hours light and 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: electric clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL dose
- Concentration (if solution): substance tested undiluted (as supplied)
Duration of treatment / exposure:
Approximately 4 hours of exposure.
Observation period:
Dermal responses were evaluated approximately 45 minutes, 24, 48 and 72 hours following patch removal.
Number of animals:
6 females.
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed, using reverse osmosis water and papers towels.
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the Draize Method of Scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No animal death prior to study termination.
Topical application of MRD-90-903 elicited no responses in any animal.
Other effects:
No additional data.

Any other information on results incl. tables

Table 7.3.1/1: 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

0/0/0/0/0/0

0/0/0/0/0/0

48 h

0/0/0/0/0/0

0/0/0/0/0/0

72 h

0/0/0/0/0/0

0/0/0/0/0/0

Average 24h, 48h, 72h

0.0

0.0

Reversibility*

-

-

Average time (unit) for reversion

-

-

*Reversibility: c. = completely reversible;= not completely reversible; n. = not 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, MRD-90-903 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 as similar to OECD guideline N°404 in compliance with GLP, six young adult female New Zealand White rabbits were dermally exposed to 0.5 mL of MRD-90-903. Test sites were covered with a semi-occlusive dressing for 4 hours. The skin reactions were assessed at 45 minutes, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times for all animals at 24, 48 and 72 hours after patch removal.

The mean scores over 24, 48 and 72 hours were 0.0 for erythema and for oedema.

Based upon the directive 67 /548/EEC and the CLP Regulation 1272/2008, MRD-90-903 is not considered as irritating to the rabbit skin.