3-chloropropane-1,2-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-01-20 to 2010-03-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to scientifically accepted and recommended ICCVAM protocol

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: HET-CAM Test following ICCVAM recommended test method protocol dated November 2006

Deviations:

no

Principles of method if other than guideline:

Exposure of chorioallantoic membrane of chicken egg's in order to detect potential irritancy of substances. The test substance is directly applied to the membrane which is then observed for haemorrhage, vascular lysis and coagulation. A scoring system using these three factors determines the irritant potency of the substance.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-chloropropane-1,2-diol

EC Number:

202-492-4

EC Name:

3-chloropropane-1,2-diol

Cas Number:

96-24-2

Molecular formula:

C3H7ClO2

IUPAC Name:

3-chloropropane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): 3-Chloro-1,2 propane diol
- Physical state: Liquid
- Composition of test material, percentage of components: 3-chloro-1,2-propane diol, > 98%
- Analytical purity: 99,3% (GC)
- Lot/batch No.: 5225
- Expiration date of the lot/batch: 17/11/2010
- Storage condition of test material: Stored in a closed vessel at room temperature protected from light
- Stability: unknown
- Other: date of production: 17 Nov 2009

Test animals / tissue source

Species:

other: Chicken Eggs

Strain:

other: Lohmann Leghorn

Details on test animals or tissues and environmental conditions:

INFORMATION ON EGGS
- Source: LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany)
- Age at study initiation: 9 days


INCUBATION CONDITIONS
- Incubation period: 8 days
- Type of incubator: Still air incubator
- Temperature (°C): 38.5
- Humidity (%): 58 ± 3

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 µL

Duration of treatment / exposure:

300 seconds

Observation period (in vivo):

300 seconds

Number of animals or in vitro replicates:

3 eggs per control group and 6 eggs for the treatment group

Details on study design:

Negative control: 0.9% NaCl
Positive controls: 1% Sodium dodecyl sulfate and 0.1 M NaOH

CAM preparation: The eggs were candled and the air bubble was marked. The egg was opened on the air bubble with a rotating dentist's saw blade. The inner membrane was moistened with 0.9% NaCl, then the egg was left to stand into the incubator for 30 min. After this period, the solution was decanted and the inner membrane was carefully removed with a forceps. Then the test items were given directly onto the CAM surface.

SCORING SYSTEM: Irritant score (IS) was based on haemorrage, vascular lysis and coagulation. In order to determine the IS the following formula was applied: IS = [(301-time until haemorrage)/300]*5 + [(301-time until lysis)/300]*7 + [(301-time until coagulation)/300]*9.
Following categories of scores were used: 0-0.9 (not irritant), 1-4.9 (slightly irritant), 5-8.9 (moderately irritant and 9-21 (severely irritant).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Score:

19.59

Max. score:

19.9

Remarks on result:

other: Classification: severely irritant

Irritant / corrosive response data:

Negative control: mean irritation score of 0.00
Positive control 1% SDS: mean irritation score of 19.98
Positive control 0.1 M NaOH: mean irritation score of 11.14

Any other information on results incl. tables

Values for negative controls were within the range of historical data and met the predetermined criteria. Values for positive controls met the predetermined criteria, however values were not in the range of historical data. This was considered uncritical as the deviation was only a little above the respective historical range. Variation of biological systems within this order of magnitude is not unusual and therefore the test system was considered valid.

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: ICCVAM recommened HET-CAM protocol (Nov. 2006)

Conclusions:

The substance can be considered as a severe irritant in the current valid HET-CAM test.
Although the HET-CAM test method is not yet validated, the EU national regulatory authorities accept positive outcomes (severe eye irritants) of this test method for the classification and labelling of severe eye irritants. Therefore the substance should be classified as Xi R41 (under DSD) and Eye damage category 1 H318 (under CLP).