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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:
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Test material form:
liquid: viscous
Details on test material:
- Manufacturers identification: Novares TL 10, Novares L 100, Novares L 800, Novares C 10 (different types/technical products of the substance)
- Substance type: organic
- Test material is 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised', EC list number 701-299-7 (assigned by ECHA after request for change of EC number/EC name). Originally, the substance Hydrocarbons, C9-unsaturated, polymerised, CAS No. 71302- 83-5, was submitted for registration. Subsequent to substance validation, the identity of the substance was changed by ECHA (EC number 615-276-2 and new name 'Distillates (petroleum), steam-cracked, C8-12 fraction", mainly C8 - C10 unsaturated aromatic and alkylaromatic hydrocarbons, predominantly styrene- and indene-derivatives, obtained by Lewis acid-initiated alkylation and polymerisation').
- for additional information see respective study records
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

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
albino rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Details unknown

ENVIRONMENTAL CONDITIONS
- Details unknown


Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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'.

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

 

Applicant's summary and conclusion

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.