Alkanes, C10-13, chloro

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reporting, but data condsidered adequate for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Report date:

1966

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Limited reporting (only very brief details on test method and results)

GLP compliance:

no

Remarks:

Prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Alkanes, C10-13, chloro

EC Number:

287-476-5

EC Name:

Alkanes, C10-13, chloro

Cas Number:

85535-84-8

IUPAC Name:

Alkanes, C10-C13, Chloro

Details on test material:

- Name of test material (as cited in study report): "40% chlorinate of C10-13 normal paraffin"
- Substance type: technical product
- Physical state: white liquid
- Analytical purity: no data
- Impurities (identity and concentrations): 1% Abrac A (epoxydised soya oil) added as a stabliser
- Composition of test material, percentage of components: C10-13 chlorinated paraffin (40% chlorination)
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.:
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:

rabbit

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

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): "one drop" [presumably about 0.1 ml]

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3

Details on study design:

no data

Results and discussion

In vivo

Results

Irritation parameter:

other: no scores given, description of physical signs only

Basis:

other: all animals

Time point:

other: 24 h

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: mild congestion seen at 1 h which had completely resolved by 24 h

Irritant / corrosive response data:

No immediate reaction, but mild congestion seen at 1 h which had completely resolved by 24 h.

Other effects:

no data

Any other information on results incl. tables

No irritation scores given.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

When applied to the right eye of each of three rabbits, a C10-13 chlorinated paraffin (40% chlorination) caused mild congestion after 1 h, which had completely resolved within 24 h.

Executive summary:

In an assessment of its potential to induce eye irritation, a drop of undiluted C10-13 chlorinated paraffin (40% chlorinatation) was placed into the right eye of each of three rabbits and observations were made over a 3-day period. Mild congestion was evident after 1 h but this had completely resolved within 24 h.

Under the conditions of this study, this C10-13 chlorinated paraffin would not be classified as an eye irritant according to EU CLP and DSD regulations.