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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

- Skin irritation/corrosion: irritating (based on results of a reliable OECD 404 study for a related substance, covering the carbon numbers in the range C7-C10).

- Eye irritation: not irritating (based on results of a reliable OECD 405 study for related substances, covering the carbon numbers in the range C7-C10).

- Respiratory irritation: The conclusion of not irritant to the respiratory tract is based on the absence of significant irritating effects on the eye.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, see "Principles of method if other than guideline"
Principles of method if other than guideline:
Deviations: During the study period, the temperature of the animal room ranged from 21° to 24°C and the relative humidity ranged from 62 to 78%.
According to the OECD guideline 404 the temperature of the experimental animal room should be 20°C (± 3°C) and the relative humidity 30% to 70%. Both deviations are not considered to have an effect on the validity of the study.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
24 h
Observation period:
14 d
Number of animals:
6
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
24 h
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
other: 96 h
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
14 d
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
24 h
Score:
1.5
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
other: 96 h
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
14 d
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritant / corrosive response data:
all individual dermal irritation scores i.a. for treatment on intact area: see 'Attached Background material'
Other effects:
The test material produced slight to severe levels of irritation to the skin of rabbits as a result of 24-hour exposure. Blanching was seen within the
test sites of one animal at 96 hours. A possible necrotic area was seen at the test site of four animals at 7 days. No signs of ill health were seen during the study.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
On the basis of the test results and in conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' should be classified as 'irritating'.
Executive summary:

A dermal irritation study in rabbits was performed (similar to OECD Guideline 404) on 'Light-alkylated Naphtha' (CAS 64741-66-8).

The test material produced slight to severe levels of irritation to the skin of rabbits as a result of 24-hour exposure. Blanching was seen within the test sites of one animal at 96 hours. A possible necrotic area was seen at the test site of four animals at 7 days.

7 days after exposure, the dermal irritation score were 2 or higher in 4/5 animals. 14 days after exposure maximum 2/5 animals showed dermal irritation score of 2 or more. No signs of ill health were seen during the study.

On the basis of the test results and in conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' should be classified as 'irritating' (skin irrit. 2; H315).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, see "Principles of method if other than guideline"
Principles of method if other than guideline:
Deviation: During the study period, the temperature of the animal room ranged from 21° to 24°C. According to the OECD guideline 405 the
temperature of the experimental animal room should be 20°C (± 3°C). This deviation is not considered to have an effect on the validity of the study.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (eyes unflushed after dosing);
3 animals (eyes flushed 1 min after dosing with lukewarm water)
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritation parameter:
chemosis score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritation parameter:
chemosis score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
0
Max. score:
0
Remarks on result:
other: eyes not flushed with water after treatment
Irritant / corrosive response data:
all individual eye irritation scores: see 'Attached Background material'
Other effects:
- no pain response (vocalization) was elicted from any animal following instillation of the test material
- no signs of ill health were observed during the study
Interpretation of results:
GHS criteria not met
Conclusions:
No corneal or iridial irritation was seen during the study. All irritation had cleared by the 24-hour observation. On the basis of the test results and in
conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' should be not classified as 'irritating'.
Executive summary:

An eye irritation study in rabbits was performed (similar to OECD Guideline 405) on Light-alkylated Naphtha (CAS 64741-66-8), which is a near analogue to 'Naphtha (Fischer-tropsch), light, C4-10 - branched and linear'. No corneal or iridial irritation was seen during the study. All irritation had cleared by the 24-hour observation.

On the basis of the test results and in conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' should not be classified as ' irritating'.

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

Respiratory irritation

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

Additional information

There are no irritation/corrosion data available of ‘Naphtha (Fischer-Tropsch), light, C4-C10 branched and linear’. However, studies were performed to assess the skin and eye irritation potential of the closely related substance ‘Naphtha (petroleum), light alkylate’ (covering the carbon numbers in the range C7-C10):

The skin irritation study was conducted in accordance with OECD 404 and GLP. The test material produced slight to severe levels of irritation to the skin of rabbits as a result of 24-hour exposure. Blanching was seen within the test sites of one animal at 96 hours. A possible necrotic area was seen at the test site of four animals at 7 days. 7 days after exposure, the dermal irritation score were 2 or higher in 4/5 animals. 14 days after exposure maximum 2/5 animals showed dermal irritation score of 2 or more. No signs of ill health were seen during the study. On the basis of the test results and in conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' and the closely related 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' are classified as 'irritating' (skin irrit. 2; H315).

The eye irritation study was conducted in accordance with OECD 405 and GLP. No corneal or iridial irritation was seen during the study. All irritation had cleared by the 24-hour observation. On the basis of the test results and in conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' and the closely related 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' were found to be not irritating to the eye.

Justification for selection of skin irritation / corrosion endpoint:

No skin irritation/corrosion data are available for the substance defined in section 1. For the endpoint conclusion a study of a related substance with a limited range (C7-C10) was selected.

Justification for selection of eye irritation endpoint:

No eye irritation data are available for the substance defined in section 1. For the endpoint conclusion a study of a related substance with a limited range (C7-C10) was selected.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on read-across from the closely related substance ‘Naphtha (petroleum), light alkylate’ (covering the carbon numbers in the range C7-C10), skin irritating effects are expected from the exposure to ‘Naphtha (Fischer-Tropsch), light, C4-C10 branched and linear’. Therefore, the substance is considered as skin irritant and classified as skin irrit. 2, H315 (EU-GHS). Moreover, based on read-across from the same substance ‘Naphtha (petroleum), light alkylate’, the eye irritating potential of ‘Naphtha (Fischer-Tropsch), light, C4-C10 branched and linear’ is conclusive but not sufficient for classification.

The conclusion of not irritant to the respiratory tract is based on the absence of significant irritating effects on the eye.