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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

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Administrative data

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

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 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

Test material

Constituent 1
Reference substance name:
Naphtha (petroleum), light alkylate
EC Number:
265-068-8
EC Name:
Naphtha (petroleum), light alkylate
Cas Number:
64741-66-8
IUPAC Name:
Naphtha (petroleum), light alkylate
Details on test material:
- Name of test material (as cited in study report): Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Test substance is closely related to Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear; it is defined as : 'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

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)

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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'.