Registration Dossier

Administrative data

Description of key information

The substance ‘Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised’ (NAF-AO) [EC no. 701-299-7] (see Chapt. 1) showed only weak/very weak irritation responses in test for skin and eye irritation. When applying criteria of the CLP regulation, NAF-AO was assessed to be neither skin nor eye irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Pre-GLP study, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
pre-guideline study
Deviations:
yes
Remarks:
24h occlusive exposure, only two readings at 24 and 72 h, scarified/abraded skin included
Principles of method if other than guideline:
The test procedure follows the test method described in "METHOD OF TESTING PRIMARY IRRITANT SUBSTANCES" from US Code of Federal Regulations (CFR) Title 16, Section 1500.41, which is comparable to OECD TG 404.
GLP compliance:
no
Remarks:
pre-GLP study
Specific details on test material used for the study:
- Name of test material (as cited in study report): Produkt-Nr.: 161 001 (additional name: Cumaron-Inden Harz B1 flüssig) (early technical product of the substance 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised')
- no further information
Species:
rabbit
Strain:
not specified
Remarks:
albino rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Details unknown

ENVIRONMENTAL CONDITIONS
- Details unknown


Type of coverage:
occlusive
Preparation of test site:
other: abraded or intact and shaved
Vehicle:
unchanged (no vehicle)
Remarks:
according to method description in study report
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- % coverage: no data
- Type of wrap if used: the test material is covered with surgical gauze, two single layers thick. In addition, the entire trunk of the animal is wrapped with an impervious material such as rubberised cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

OBSERVATION TIME POINTS
- after removal of patches/cover and 48 hrs thereafter; 24 and 72 hrs after application

SCORING SYSTEM (see method description in the test report under 'Attached full study report')
- Evaluation of skin irritation: skin effects are evaluated according to the scoring system of Draize
- Method of calculation: primary irritation score is calculated according to the procedure described in the test method
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
over 6 animal, two time points and two application forms: total of individual scores for erythema and oedema divided by (6x4)
Time point:
other: 24 + 72 h
Score:
1.5
Max. score:
8
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
0.833
Max. score:
4
Reversibility:
not specified
Remarks:
observation period is only 72 hrs; with regard to the low erythema score, full reversibility is expected within a period of 14 days
Remarks on result:
other: maximum erythema score was 1 (5 animals)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks:
observation period is only 72 hrs; with regard to the low erythema score, full reversibility is expected within a period of 14 days
Remarks on result:
other: maximum erythema score was 1 (6 animals)
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks:
observation period is only 72 hrs; with regard to the low edema score, full reversibility is expected within a period of 14 days
Remarks on result:
other: maximum edema score was 1 (3 animals)
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
0.167
Max. score:
4
Reversibility:
not specified
Remarks:
observation period is only 72 hrs; with regard to the low edema score, full reversibility is expected within a period of 14 days
Remarks on result:
other: maximum edema score was 1 (1 animal)
Irritant / corrosive response data:
Six animals were tested for skin irritation response. The maximum score observed for erythema and edema was 1 (total maximum score 4). For erythema, no decline was noted from observation at 24 hrs to the observation at 72 hrs. But due to the only slight erythema formation (maximum grade 1), it is expected that effects are fully reversible withinan observation period of 14 days.
For edema formation, a substantial decline of effects was noted from the observation at 24 hrs to the reading at 72 hrs (at 24 hrs 3 animals with score 1, at 72 hrs only 1 animal with score 1). Effects are expected to be fully reversible.
All readings are summaries in the table under 'Any other information on results incl. tables'.

Individual scores

 

Animal #

Skin effect

24 hours

72 hours

Left side
(intact skin)

Right side
(abraded skin)

Left side
(intact skin)

Right side
(abraded skin)

1

Erythema

1

1

1

1

Oedema

1

1

0

0

2

Erythema

0

0

1

1

Oedema

1

1

0

1

3

Erythema

1

1

1

1

Oedema

0

1

0

1

4

Erythema

1

1

1

1

Oedema

0

1

0

1

5

Erythema

1

1

1

1

Oedema

1

1

1

1

6

Erythema

1

1

1

1

Oedema

0

1

0

0

 

Interpretation of results:
other: study not suited for classification; results observed in the study provide strong evidence that the substance is not irritating to skin.
Conclusions:
It can be concluded that this technical product representing the substance NAF-AO is not irritating under current test standards.
Executive summary:

In this study, the test material was applied to the skin of six rabbits for 24 hours. The rabbits were observed over 72 hours with readings at 24 and 72 hours after application. Results indicate that the test material caused slight irritation to the skin under test conditions, not classifiable to current standards. But taking into account the overall irritating response, it is assessed that criteria for skin irritation according to CLP regulation are not met.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Pre-GLP study, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
pre-guideline study
Principles of method if other than guideline:
The test procedure follows the test method described in "TEST FOR EYE IRRITANTS" from US Code of Federal Regulation (CFR), Title 16, Section 1500.42, which is comparable to OECD TG 405.
GLP compliance:
no
Remarks:
pre-GLP study
Specific details on test material used for the study:
- Name of test material (as cited in study report): Produkt-Nr.: 161 001 (additional name: Cumaron-Inden Harz B1 flüssig) (early technical product of the substance 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised')
- no further information
Species:
rabbit
Strain:
not specified
Remarks:
albino rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Details unknown

ENVIRONMENTAL CONDITIONS
- Details unknown
Vehicle:
unchanged (no vehicle)
Remarks:
according to method description in the study report
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE:
- Washing (if done): no data

SCORING SYSTEM: according to Draize, published by Food and Drug Officials of the USA, 1959 (see below); in this system, scores are included for the area of cornea affected and for discharge. Total maximum score is 110.

TOOL USED TO ASSESS SCORE: ETAD classification scheme (see below)
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
1.4
Max. score:
110
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.278
Max. score:
3
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: effects were only noted at the 24 h reading (5 animals with score 1). At later time points, no effects were observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.389
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: chemosis was note in 4 animals at the 24 h reading (score 1) and in 3 animals at the 48 h reading (score 1). Effects had subsided at day 3
Irritant / corrosive response data:
Six animals were tested for eye irritation response. No effects were noted at the cornea and iris of the test animals. Conjunctival redness and oedema (chemosis) observed in some animals were only low grade (maximum score 1). Conjunctival redness had subsided at day 2 (48-h reading), and chemosis had disappeared at day 3 (72-h reading). Responses for corneal opacity, iritis, conjunctival redness and/or chemosis above the criteria for eye irritation of Regulation (EC) 1272/2008 (CLP regulation) were not observed in any animal.

Individual scores

Animal No.

Examination of

Day

1

2

3

7

1

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Redness

1

0

0

0

Chemosis

1

1

0

0

Discharge

0

0

0

0

Draize score

 

4

2

0

0

2

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Redness

1

0

0

0

Chemosis

1

1

0

0

Discharge

0

0

0

0

Draize score

 

4

2

0

0

3

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

0

0

0

0

Draize score

 

2

0

0

0

4

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

0

0

1

0

Draize score

 

2

0

2

0

5

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Redness

1

0

0

0

Chemosis

1

1

0

0

Discharge

0

0

0

0

Draize score

 

4

2

0

0

6

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

0

0

0

0

Draize score

 

2

0

0

0

 

Total Draize score

18

6

2

0

Interpretation of results:
GHS criteria not met
Conclusions:
This test material representing the substance NAF-AO is not irritating to the eye compared to current test standards.
Executive summary:

In this study, the test material (0.1 mL) was applied to one eye of each of six test animals (albino rabbits). The rabbits were observed for 7 days. Readings were taken at 24, 48, and 72 hours using the scoring system of Draize (published by the Food and Drub Officials of the United States, 1959). Results indicate that application of the test material caused slight but non classifiable irritation to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Corrosive/irritating properties of the substance NAF-AO were investigated in two studies performed bevor OECD test guidelines were available. The test procedures adopted are published in the US Code of Federal Regulations (CFR), Title 18, Sections 1500.41 and 1500.42.

Skin irritation

The skin irritation study performed is comparable to OECD TG 404. Major differences are the reading times (only 24 and 72 hours after test material application) and the observation period (72 hours). The scoring system (Draize) is similar to the scoring system of OECD TG 404. Thus, the scores noted can be directly used to evaluate the skin irritating potential of the test material.

The skin irritating effects of the test materials, observed on six test animals (albino rabbits), were weak. Even applied under occlusive wrapping for 24 hours, scores did not exceed 1, and not all of the animals even showed an irritating response. Due to the lack of the 48-h reading and the short observation period, a thorough evaluation of the test data according to the criteria of Regulation (EC) 1272/2008 (CLP regulation) is not possible. But, based on the low grades of the irritating response, it is assessed that effects seen at the 72-h reading will subside within an observation period of 14 days. Overall, the criteria for skin irritation of the CLP regulation are assessed not to be exceeded.

Eye irritation

The eye irritation study performed is comparable to OECD TG 405. The observation period in the test was only 7 days. But this is of no importance, as all eye irritation responses noted had subsided after three days. The scoring system (Draize) is similar to the scoring system of OECD TG 405. Thus, the scores noted can be directly used to evaluate the eye irritating potential of the test material.

The eye irritating response of the test materials, evaluated on six test animals (albino rabbits), was weak. Effects on cornea and iris could not be observed at all. Maximum scores for conjunctival redness and oedema (chemosis) were 1 and effects had disappeared 72 hours after application. Evaluation of the test data demonstrates, that criteria for eye irritation of the CLP regulation are complied with.

Respiratory irritation

There is no experimental data for respiratory irritation. But, based on long-term occupational experience, there is no evidence to suggest that the substance may cause respiratory irritation.

Justification for classification or non-classification

The substance ‘Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised’ [EC no. 701-299-7] (see Chap. 1) did not cause significant skin corrosion or irritation. Similarly, no significant eye irritation was observed. Thus, classification for skin irritation as well as for eye irritation according to Regulation (EC) No 1272/2008 (CLP regulation) is not required.