Registration Dossier

Administrative data

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:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
according to the Federal Register of the F.D.A. 28 (110), 6.6.1963, para. 191.12. Test for eye irritants
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SBP 100/140
- Analytical purity: 100% pure commercial product
- Composition of test material, percentage of components: low aromatic content solvent consisting of about 35% C7, 50% C8 and 15% C9 saturated hydrocarbon isomers

Before the current ECHA nomenclature rules became effective, we adopted the IUPAC name Hydrocarbons, C7-9, n-alkanes, isoalkanes, cyclics (EC number 920-750-0) as the identifier for the substance and this was the name that was used during the pre-registration phase of REACH. Also during this time, samples of the product were collected and the required physicochemical studies were conducted. The resulting robust studies summaries were entered into the IUCLID dossier using this name and EC number.

Between 2008 and 2009 ECHA issued a specific document about the nomenclature to be used under REACH, the so called REACH Implementation Project 3.10. The implications of this document to the appropriate nomenclature for the registered substance were only fully understood by us beginning in late 2009/early 2010.

As such, during the creation of the robust study summaries in IUCLID, the discrepancy with the substance naming was not noticed. As a result, it appears in IUCLID that the tested substance indicated is not the same as the registered one; however, if robust study summaries and/or associated study reports use the substance name “Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics,” they are actually referring to the registered substance “Hydrocarbons, C7-C8, n-alkanes” according to the revised REACH nomenclature rules.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: albino
- Source: Ranch Rabbits, Crawley, Sussex
- Weight at study initiation: 3 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.2 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 males, 2 females
Details on study design:
Undiluted solvent was instilled into the conjunctival sac of the right eye of two male and two female albino rabbits; the untreated left eye served as a control. A visual assessment of irritancy was made half an hour after application and again 1, 2, 3 and 7 days later.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0.5 hrs - 7 days
Score:
0
Max. score:
4
Reversibility:
not specified

Any other information on results incl. tables

Conjunctiva redness, chemosis and discharge, Cornea opacity and area, and Iris were scored in 4 animals. In all 4 animals only at timepoint 0.5 hr a very mild irritancy was observed in conjunctiva redness and scored 0 - 1. Thus the overall score can be considered to be 0.

Table: Individual Eye Irritation Scores

Animal

1/2 hr

24 hrs

48 hrs

72 hrs

7 days

1351 Female

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

1352 Male

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

1422 Female

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

1423 Male

Cornea, opacity

0

0

0

0

0

Cornea, area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctiva, redness

0-1

0

0

0

0

Conjunctiva, chemosis

0

0

0

0

0

Conjunctiva, discharge

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU, GHS, 2007
Conclusions:
The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.
Executive summary:

The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.