C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1977-06-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because the study was carried out according to the general procedure 16 CFR 1500.42, which closely follows OECD 405, but it does not report on GLPs.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Though GLP guidance information is not presented, the study closely follows OECD guidance 405

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons

EC Number:

700-762-0

Molecular formula:

All molecules present in the mixture have the general molecular formula CnH2n for olefins or CnH2n+2 for the paraffin’s with n being an even number

IUPAC Name:

C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand; strain not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1millilitre
- Concentration (if solution): Not provided

Duration of treatment / exposure:

72

Observation period (in vivo):

24, 48, and 72 hours

Number of animals or in vitro replicates:

6, sex not specified

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

SCORING SYSTEM: Draize method of scoring eye irritation (Draize 1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24

Score:

ca. 2.7

Reversibility:

not specified

Remarks on result:

other: The maximum score is not specified in the study report; it is usually 110 if using Draize eye irritation scoring system.

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48

Score:

ca. 1

Reversibility:

not specified

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72

Score:

ca. 0

Reversibility:

not specified

Irritant / corrosive response data:

Five of the six rabbits experienced mild conjunctivitis, which disappeared after two days. No other signs of irritation were noted. No corrosion data was reported.

Other effects:

Besides mild conjunctivitis, no other effects were reported.

Any other information on results incl. tables

Five of the six rabbits experienced mild conjunctivitis, which disappeared after two days. No other signs of irritation were noted. Based on visual assessment, the test material was classified as practically non-irritating to rabbit eyes and was not considered an ocular irritant. 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Ethyl compound 100-606 is not considered to be an eye irritant to rabbits

Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for the poly alpha olefin 1-dodecene polymer with 1-decene hydrogenated (CAS number 151006-60-9) using alkane 5 (1-decene 1-dodecene homoploymer) as an analog. Both of these compounds are poly alpha olefins, i.e., highly branched isoparaffinic chemicals produced by oligomerization of 1-octene, 1-decene, and/or 1-dodecene. They have similarities in chemical structure and physiochemical properties. The literature also indicates that alkanes with 30 or more carbon atoms are unlikely absorbed when administered orally. In turn, studies indicate that they have similar health effect endpoints. Both of these poly alpha olefins have low order acute toxicity and repeated dose toxicity. Additionally gene mutations assays in bacterial cells, as well as in vitro chromosomal aberrations in mammalian cells assays demonstrate no evidence of genotoxicity regardless of metabolic activation. In vivo chromosomal aberrations assays in rats and mice also show no mutagenic potential regardless of metabolic activation. There do not appear to be any toxicological differences between 1-dodecene polymer with 1-decene hydrogenated and alkane 5. Therefore, read across between 1-dodecene polymer with 1-decene hydrogenated and alkane 5 can be justified.

In an acute eye irritation study, six rabbits (sex and strain not specified) were instilled with 0.1millilitre of Ethyl Compound 100-606 in the right eye. The left eye served as control. The treated animals were observed for any signs of injury to the cornea, iris and bulbar and palpebral conjunctivae at 24, 48, and 72 hours after treatment. The Draize method (1959) of eye irritation scoring was used.

 

Five of the six rabbits experienced mild conjunctivitis, which disappeared after two days. No other signs of irritation were noted. Based on visual assessment, the test material was classified as practically non-irritating to rabbit eyes and was not considered an ocular irritant.

 

This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because the study was carried out according to the general procedure 16 CFR 1500.42, which closely follows OECD 405, but it does not report on GLPs. 

 

This study will influence the DNEL(s).