Registration Dossier

Administrative data

Description of key information

Irritating to the skin.
Not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Cunicole de Val de Selle, Prouzel, France
- Weight at study initiation: average weight: 2.4 ± 0.05 kg
- Housing: individually housed; polystyrene cages with feeding bottles and troughs
- Diet: Lapins entretien référence 112 C (U.A.R., Villemoisson-sur-Orge, France); ad libitum during the study
- Water: filtered drinking water; ad libitum during the study
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin areas of the test animals served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
15 days after application (at 1, 24, 48, 72 hours and thereafter daily)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 square centimetre
- Type of wrap if used: gauze bandage and compress


SCORING SYSTEM: OECD Draize Scoring System
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
other: reversible on day 8, but dryness of the skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: reversible on day 9, but dryness of the skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
At 1 hour after exposure, erythema were observed for all three animals and edema for two of three animals.
Interpretation of results:
other: Irritating
Remarks:
Criteria used for interpretation of results: other: GHS (EU, 2007)
Conclusions:
The test substance was irritating to the skin according to the criteria of the EU and the GHS.
Executive summary:

The test substance was irritating to the skin according to the criteria of the EU and the GHS.

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 September 2000 - 26 July 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc. (formerly HRP), Denver, PA, USA
- Age at study initiation: approximately 15 - 16 weeks
- Weight at study initiation: 2.41 - 2.73 kg
- Housing: single housed during study; suspended stainless steel and wire mesh with absorbent paper below cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Diet 5322; feed was analysed and not contaminated; the animals received new feed each day and the old feed, if any, was discarded. Availability of feed was checked at least once daily for all animals.
- Water (e.g. ad libitum): ad libitum, automatic watering system; water was analysed and not contaminated; availability of water was checked at least once daily for all animals
- Acclimation period: 22 days; animals were examined for viability at least once daily
- Other: animal identification by ear tags and corresponding cage identification


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 - 22.2°C (64 - 72 degrees Fahrenheit)
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): approx. 12 h light (06.00 - 18.00) and 12 h dark (18.00 - 06.00)
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
see observation period: The test substance was not washed out.
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize Standard Eye Irritation Grading Scale (Draize 1959: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the US, vol. 49, pp. 2-56.

TOOL USED TO ASSESS SCORE: 2 % sodium fluorescein
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
Ocular instillation of the test substance elicited conjunctival responses in all animals. Iridic and corneal responses were not evident during the study. Conjunctival responses consisted of redness of Grade 2 in all animals and discharge of Grade 1 and Grade 2 for one animal each at the 1 hour evaluation. Discharge was not evident after the 1 hour evaluation but redness of Grade 1 was noted for 2 animals at the 24 and 48 hour evaluations. Redness of Grade 1 also was noted for all animals at 72 hour evaluation. Irritation was not evident at the Day 7 evaluation and the study was terminated.
Other effects:
All animals survived the study termination and were free of clincial signs during the study.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: other: GHS (EU, 2007)
Conclusions:
Based on the study design the test substance, hydrocarbons, C7-C9, isoalkanes, is not irritating.
Executive summary:

Based on the study design the test substance, Hydrocarbons, C7-C9, isoalkanes, is not irritating.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritation potential of the test substance was determined according to OECD 404 (Total Solvants, 2000). The test substance was applied to the intact skin of rabbits for 4 hours under semiocclusive conditions. After removal of the test substance, no edema, but well-defined to moderate erythema were noted in all three animals. Irritating effects were reversible within 9 days. Under the test conditions, the test substance was irritating to the skin.

The eye irritation potential of the hydrocarbons, C7-C9, isoalkanes was determined by instillation of 0.1 mL of the test material into the conjunctival sac of 3 rabbits (ExxonMobil, 2004). Ocular reactions were examined and scored 1, 24, 48, 72 hours after application. At the 1 hour evaluation, conjunctival redness (grade 2) was observed in all animals. Conjunctival redness (grade 0-1) was also noted in all animals at the 72 hour evaluation. All redness was reversible within 7 days. No corneal opacity, iritis or conjunctival chemosis was noted in any of the 3 rabbits. Two further studies, performed according to OECD 404) showed that no ocular irritation in any animal at any time point could be observed for the compounds ISOPAR E and ISOPAR C (both studies from ExxonMobil, 1997). In another study of ExxonMobil (1977) conducted similar to OECD 405, at 1 hour after administration, 4 of 6 animals showed slight erythema which completely subsided by the 4 hour observation. The remaining 2 animals showed slight or moderate erythema, slight edema, and slight discharge. These irritating effects were fully reversible within 72 hours after administration.Under the test conditions, the test substance was not irritating to the eyes.

Justification for classification or non-classification

Based on the available data, hydrocarbons, C7-C9, isoalkanes were considered as skin irritant.

CLP: Skin Irritation Category 2

 

The available data on the eye irritating potential of hydrocarbons, C7-C9, isoalkanes, are conclusive but not sufficient for classification.