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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
OECD requirement for this test is for 4 hr exposure (and not 24 hr); semi-occlusive exposure (standard) vs occlusive exposure; abraded skin also included; and no 48 hr reading was performed.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
RAEs are not expected to be more hazardous than DAE; therefore, read across to DAEs represents a conservative approach.

- Name of test material (as cited in study report): API 83-16 Light Paraffinic Distillate Solvent Extract
- Physical state: Liquid, brown

- Viscosity, SSU: 67.2 at 100°F
- API Gravity: 16.7
- Flash Point: (°F) 335
- Pour Point (°F): 20
- Aniline Point (°F): 95.5
- Sulfur, Wt %: 2.64

- Composition of test material ASTM D-2007, Wt. %:
Saturates: 29.2
Aromatics 68.6

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania
- Weight at study initiation: 2834 grams (mean)
- Housing: Maintained individually in screen-bottom cages
- Diet (e.g. ad libitum): Purina certified rabbit chow 5322 ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24
- Humidity (%): 56 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 06-12-1984 To: 20-12-1984

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Abraded and intact site on each rabbit
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per area
Duration of treatment / exposure:
24 hour
Observation period:
24 and 72 hours, 7 and 14 days
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: One intact site and one abraded site per rabbit
- Type of wrap if used: 2.5x2.5 cm gauze patch, secured with paper tape and overwrapped with saran wrap and elastoplast tape to maintain the test material in contact with the skin and decrease the rate of evaporation

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with wet disposable paper towels
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
24 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
72 h
Score:
2.2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
24 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
The test material produced slight to severe levels or irritation to the skin of rabbits.
Other effects:
No sign of ill health was observed during the study.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified under EU DSD criteria; exposure period was 24 hours
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the mean (24 and 72 hour, intact skin) erythema and oedema scores were 2.45 and 2.5, respectively.
Executive summary:

Justification for Read Across

For purposes of classification and labelling and registration under REACH, aromatic extracts are sub-divided into the categories of distillate aromatic extracts (DAE), treated distillate aromatic extracts (TDAE), and residual aromatic extracts (RAE). Some of the classifications are based on 3-7 ring PAC content, which is not substantively affected by whether the aromatic extract is derived from paraffinic or naphthenic or “light” or “heavy” crude. Therefore, DAEs and RAEs are not subclassified based on crude oil source or viscosity. For most health endpoints, data from any one of the DAEs can be “read-across” to the remaining DAEs and whole RAE category.

In a primary dermal irritation study, white rabbits (6 male) were dermally exposed to 0.5 mL of light paraffinic distillate solvent extract for 24 hours to both an intact skin site and abraded skin site. Animals then were observed for 14 days. Irritation was scored by the method of Draize (1959). The mean (24 and 72 hour, intact skin) erythema and oedema scores were 2.45 and 2.5, respectively.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 404.