Alkanes, C14-17, chloro

Eye irritation

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: Limited reporting; however study considered adequate for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rabbits were given a single application of a C14-17 chlorinated paraffin (chlorinated to either 40 or 45%) into the conjunctival sac of one eye and observed for up to 7 days.

GLP compliance:

no

Remarks:

Prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Alkanes, C14-17, chloro

EC Number:

287-477-0

EC Name:

Alkanes, C14-17, chloro

Cas Number:

85535-85-9

Molecular formula:

Substance is a range of chlorinated isomers of C14 to C17 paraffin

IUPAC Name:

Alkanes, C14-17, chloro

Details on test material:

- Name of test material (as cited in study report): Meflex DC024 and Meflex DC029
- Substance type: technical product
- Physical state: pale yellow liquid
- Impurities (identity and concentrations): 0.2% epoxy soya bean oil; 0.3% lubrizol LZ55A; 0.3% polyethylene glycol; 0.2% NonoxWSL
- Composition of test material, percentage of components: Meflex DC024; a C14-17 n-paraffin, chlorinated to 40%. Meflex DC029; a C14-17 n-paraffin, chlorinated to 45%
- Stability under test conditions: "good"
- Storage condition of test material: ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: no data- Age at study initiation: no data- Weight at study initiation: 2.5 to 3.5 kg- Housing: no data- Diet (e.g. ad libitum): no data - Water (e.g. ad libitum): no data- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): no data- Humidity (%): no data- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): no dataIN-LIFE DATES: From: To: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

" One drop"

Duration of treatment / exposure:

No indication given as to whether the applied material was washed out of the eye after instillation

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

Initial pain assessed on 6 point scale and irritation asseessed as described by Draize (1959) and interpreted as described by Kay and Calandra (1962)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1-2 hr

Score:

3.3

Max. score:

110

Reversibility:

not specified

Remarks on result:

other: Meflex DC024/Meflex DC029

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

80

Reversibility:

not specified

Remarks on result:

other: Meflex DC024/Meflex DC029

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

80

Reversibility:

not specified

Remarks on result:

other: Meflex DC024/Meflex DC029

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1-2 hr

Score:

3.3

Max. score:

20

Reversibility:

not specified

Remarks on result:

other: Meflex DC024/Meflex DC029

Irritant / corrosive response data:

Both materials caused slight, transient conjuctivitis (score 3 on 1-8 scale)

Other effects:

Pain score at instillation - 2 (scale 0-5)

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated informationCriteria used for interpretation of results: expert judgment

Conclusions:

When instilled into the conjunctival sac of one eye of each of three rabbits, a single drop of Meflex DC024 (an epoxy stabilised C14-17 chlorinated paraffin; 40% chlorination) and Meflex DC029 (an epoxy stabilised C14-17 chlorinated paraffin, 45% chlorinated) produced no iridial or corneal effects over an observation period of 7 days and only mild, transient conjunctival effects.

Executive summary:

Meflex DC024 (an epoxy stabilised C14-17 chlorinated paraffin; 40% chlorinated) and Meflex DC029 (an epoxy stabilised C14 -17 chlorinated paraffin, 45% chlorinated) were assessed for their ability to cause eye irritation and corrosion by instilling one drop of the undiluted material into the conjunctival sac of one eye of each of three rabbits.

Slight initial pain (score 2 on a 6 -point scale) was noted after instillation. No iridial or corneal effects were seen up to 7 days post administration and only transient conjunctival irritation (score 3 out of 8 for conjunctival effects) was seen at 1 -2 hr post instillation.

Under the conditions of this study, Meflex DC024 and Meflex DC029 were judged to be slight eye irritants and would not be classified as capable of producing serious eye damage/eye irritation under the EU CLP and DSD regulations.