Isodecyl pivalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

24 Feb 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Principles of method if other than guideline:

HET-CAM assay with 6 eggs.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Test animals / tissue source

Species:

other: Chicken

Strain:

other: White leghorn

Details on test animals or tissues and environmental conditions:

TEST EGGS
- Source: INRA-PAP, 37380 Nouzilly,France
- Age at study initiation: 10 d
- Weight at study initiation: 50 - 60 g


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37 - 38

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: yes, negative control eggs treated with 0.9% NaCl solution, positive control eggs treated with 3% sodium lauryl sulfate

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.2 mL

Duration of treatment / exposure:

20 sec

Observation period (in vivo):

up to 5 min after exposure

Number of animals or in vitro replicates:

6 eggs (test substance)
3 eggs (0.9% NaCl solution; negative control)
3 eggs (3 % sodium lauryl sulphate; positive control)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 5 mL saline (37 °C)
- Time after start of exposure: 20 sec.


SCORING SYSTEM:
Observations were scored according to table 1.
Classification was done according to table 2

Results and discussion

In vitro

Results

Irritation parameter:

other: Primary irritancy index

Run / experiment:

mean out of 6 eggs after 30 sec, 2 min or 5 min

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: scores depending on the time point of reaction for the first time.

Other effects / acceptance of results:

No further effects reported.

Any other information on results incl. tables

Table 3: Irritation scoring - results

	Hyperaemia	Hemorrhage	Coagulation	Summed scores
Egg No. 1	0	0	0	0
Egg No. 2	0	0	0	0
Egg No. 3	0	0	0	0
Egg No. 4	0	0	0	0

The test substance had no potential to cause irritation in the HET-CAM test.

The negative control, 0.9% NaCL solution, tested in parallel, did not cause irritation in any of the eggs (IP-CAM = 0.0)

The positive control, 3% SDS, induced clear irritating phenomena on every membrane (hyperaemia and haemorrhage observed after 30 s in all 3 eggs, coagulation observed after 5 min in 1 egg). A primary irritation index, IP-CAM, of 13.7 was obtained.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Conclusions:

There is regulatory acceptance in the EU that a substance can be considered a severe eye irritant (Serious eye damage Category 1/R41) based on a positive result in one of the available in vitro test methods, e.g. the Hen's Egg Test on Chorioallantoic Membrane (HET-CAM) test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant (Category 2/R36) and shall therefore be subject to further evaluation.