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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Light paraffinic distillate solvent extract (CAS# 64742-05-8)
IUPAC Name:
Light paraffinic distillate solvent extract (CAS# 64742-05-8)
Details on test material:
Treated distillate aromatic extracts (TDAEs) are a further processing of distillate aromatic extracts (DAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from DAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). 

- Name of test material (as cited in study report): API 83-16
- Physical state: liquid, brown

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchlant, Inc., Denver, Pennsylvania
- Weight at study initiation: 2,834 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): 21-24
- Humidity (%): 56-70
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 12/06/84 To: 12/20/84

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 male
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:
other: 24 and 72 hours
Score:
2.42
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
other: 24 and 72 hours
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

Treated distillate aromatic extracts (TDAEs) are a further processing of distillate aromatic extracts (DAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from DAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). Where treatment was sufficient to reduce the 3-7 ring PACs (<3 wt% DMSO extractables as measured by IP-346), the material is most similar to a lubricating base oil and it is this data that should be used for read across. 

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. In this study, light paraffinic distillate solvent extract is not classified under EU DSD criteria; exposure period was 24 hours.

 

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.