Pentadecane, 7-methylene-, mixed with 1-tetradecene, dimers and trimers, hydrogenated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study with full report available

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: in compliance with the Federal Hazardous Substances Act 16 CFR 1500

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Remarks:

US regulation 21CFR58

Test material

Test material information

Constituent 1

Reference substance name:

68037-0-14

IUPAC Name:

68037-0-14

Constituent 2

Reference substance name:

1-decene, homopolymer, hydrogenated

IUPAC Name:

1-decene, homopolymer, hydrogenated

Details on test material:

- Name of test material (as cited in study report): Emery 3006
- Molecular formula (if other than submission substance): C10 polyalphaolefin (trimer to hexamer oligomer mixture; C30-60.H62-122)
- Molecular weight (if other than submission substance): 552 (weight average), 552 (number average)
- Smiles notation (if other than submission substance): (CCCCCCCCCC) x 3.9 average
- Substance type: hydrogenated polyalphaolefin oligomer
- Lot/batch No.: 8BU27
- Physical state: clear liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Clerco Research Farm
- Housing: individual in wire mesh suspension cages
- Diet (ad libitum): Purina rabbit chow
- Water (ad libitum): tap
- Acclimation period: 1 day minimum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 4-apr-88

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other rabbit eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Single dose

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6

Details on study design:

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

SCORING SYSTEM: Draize (1959). Cornea, iris and conjunctival effects scored to produce a single irritation index score in the range 0 min to 110 max.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - no data

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Average of 24, 48, 72 hour observations

Score:

1.8

Max. score:

4

Reversibility:

other: not possible to judge as observation period not long enough

Remarks on result:

other: Max score is maximum for any one animal at any time point.

Irritant / corrosive response data:

Corneal lesions: 0 for all animals at all time points
Iritis: 0 for all animals at all time points.
Conjunctival swelling and conjunctival erythema - see tables in field 'remarks on results' below:
Note: overall irritation score = (Degree of corneal opacityxareax5)+(Iris scorex5)+(erythema score+conjunctival score+swelling)x5. Maximum possible score is 110. Maximum score is maximum overall irritation score seen in any one animal.

Any other information on results incl. tables

Conjunctival erythema results by animal

Rabbit	1	2	3	4	5	6
24 hours	1	1	0	0	0	1
48 hours	1	1	0	1	1	1
72 hours	1	1	0	1	0	0

Conjunctival edema results by animal

Rabbit	1	2	3	4	5	6
24 hours	0	0	0	0	0	1
48 hours	0	0	0	1	0	1
72 hours	1	0	0	0	0	1

Conjunctival erythema: Average values at time points 24/48/72 hrs: 0.5/0.83/0.5. Maximum value 1. (vessels injected above normal)

Irritation scores (mean) at time points 24/48/72 hrs: 1.3/2.3/1.7

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Clearly the substance has very low acute irritation potential. It was not possible to judge full reversibility as the study was only performed for 72 hours but the very limited signs of irritation and the fact that recovery was already apparent lead to a judgement that the substance is unlikely to meet the classification criteria.

Executive summary:

In a GLP eye irritancy study in rabbits, a similar substance to "Pentadecane, 7-methylene mixed with 1-tetradecene, dimers and trimers, hydrogenated" was found to have low irritancy potential. No corneal lesions or iritis was observed at all and only mild chemosis and redness were seen. These remained present at the end of the 3 day observation period in most animals but were showing signs of reversal. Whilst it is not possible to make a definitive conclusion regarding classification, expert judgement suggests that recovery within 14 days is likely and therefore the classification criteria are not met.