Oils, fish, sulfated, ammonium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rape oil, sulfated, sodium salt

EC Number:

281-978-8

EC Name:

Rape oil, sulfated, sodium salt

Cas Number:

84082-30-4

Molecular formula:

not available (substance is a UVCB)

IUPAC Name:

Not applicable

Test material form:

liquid

Details on test material:

- Name of test material: CP12
- Lot/batch No.: 0012
- Storage condition of test material: Room temperature in the dark.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 15 - 17 weeks
- Weight at study initiation: 2.9 kg
- Housing: conventional, singly housed in metal cages with perforated noryl floors
- Diet (e.g. ad libitum): Stanrab (P) from Special Diet Services UK, ad libitum
- Water (e.g. ad libitum): Municipal supply ad libitum
- Acclimation period: at least 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2012-10-15 To: 2012-11-05

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 hours, 7, 14 and 21 days after application

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize scale, according to test guideline

TOOL USED TO ASSESS SCORE: None

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

2.3

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1.7

Max. score:

4

Irritant / corrosive response data:

Response was assessed in a single animal. Well defined conjunctival chemosis and moderate redness were observed 1, 24 and 48 hours post-exposure. Seventy-two hours after exposure, slight chemosis and severe redness were observed. Slight redness was still observed after 7 and 14 days. Slight discharge and chemosis were noted after 14 days after dosing. Slight corneal opacity with the area of cornea involved greater than half was observed from 1 hour post-exposure up to the end of the observation period (21 days after treatment). The extension of the opacity gradually decreased from 48 hour post-exposure.

AVERAGE SCORE
- Cornea: 1.0
- Iris: 0.0
- Conjuntivae (Redness): 2.3
- Conjuntivae (Chemosis): 1.7

Any other information on results incl. tables

Irritant/corrosive response data at each observation time

 

Score at time point / Reversibility	Cornea	Iris	Conjunctival redness	Conjunctival chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 minutes	1	0	2	2
24 hours	1	0	2	2
48 hours	1	0	2	2
72 hours	1	0	3	1
7 days	1	0	1	0
14 days	1	0	1	1
21 days	1	0	0	0
Average 24, 48, 72 hours	1.0	0.0	2.3	1.7

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Acute eye irritation has been investigated in the rabbit in accordance with OECD test guideline No. 405. Significant irritation was observed that had not resolved within 21 days.

Executive summary:

Acute eye irritation has been investigated in the rabbit in accordance with OECD/EU test guideline No. 405. Significant irritation was observed that had not resolved within 21 days.