Reaction mass of 1,2-Benzenedicarboxylic acid, 3-sulfo-, ammonium salt (1:3), 4-Sulphophthalic acid, ammonium salt, Ammonium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Decaltal N

IUPAC Name:

Decaltal N

Details on test material:

- Name of test material (as cited in study report): Decaltal N
- Physical state: solid, white
- Analytical purity: 99.57%
- Composition of test material, percentage of components: 15.5 g/100 g (tri ammonium 4-sulphonatophthalate), 4.5 g/100 g (tri ammonium 3-sulphonatophthalate), 0.7 g/100 g (di ammonium phthalate), 78.4 g/100g (ammonium sulfate), 0.47 g/100 g (water) (as determined by 1H-NMR-spectroscopy)
- Lot/batch No.: 89273636W0
- Expiration date of the lot/batch: November 09, 2013
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2-2.52 kg
- Housing: single housing
- Diet: STANRAB (P) SQC
- Water: tap water al libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

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 bulk volume (approx 16 mg of the comminuted test item) was applied to one eye

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

72 hrs

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hrs after test item application the treated eye of the animal(s) was rinsed then with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe


SCORING SYSTEM:
Cornea opacity (op):
0 No ulceration or opacity
1 slight: Scattered or diffuse areas of opacity (other than slight dulling of normal
lustre), details of iris clearly visible
2 moderate: easily discernible translucent area, details of iris slightly obscured
3 marked: nacreous area, no details of iris visible, size of pupil barely discernible
4 severe: opaque cornea, iris not discernible through the opacity

Area of cornea involved (ar):
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾

Area with fluorescein:
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾

Iris:
0 Normal
1 moderate: markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 severe: no reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae redness (red):
0 Blood vessels normal
1 slight: some blood vessels definitely hyperemic (injected)
2 obvious: diffuse, crimson color, individual vessels not easily discernible
3 severe: diffuse beefy red

Chemosis (sw):
0 No swelling
1 slight: any swelling above normal (includes nictitating membranes)
2 moderate: obvious swelling with partial eversion of lids
3 marked: swelling with lids about half closed
4 severe: swelling with lids more than half closed

Discharge (di):
0 No discharge
1 slight: any amount different from normal (does not include small amounts observed
in inner canthus of normal animals)
2 obvious: discharge with moistening of the lids and hairs just adjacent to lids
3 severe: discharge with moistening of the lids and hairs, and considerable area
around the eye

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean of 24, 48, 72 hrs

Score:

0.23

Max. score:

3

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: only one anmals showed slight conjunctival redness

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean of 24, 48, 72 hrs

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean of 24, 48, 72 hrs

Score:

0

Max. score:

2

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight conjunctival redness (grade 1) was noted in all animals at hour 1 and persisted up to 48 hours in one of these animals.
Slight conjunctival chemosis (grade 1) and slight or obvious discharge (grade 1 or 2) were noted in all animals 1 hour after application.
Additional findings like injected scleral vessels in a circumscribed or circular area were noted in the animals during the observation period.
The ocular reactions were reversible in all animals within 72 hours after application at the latest.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the described ocular reactions as well as the average score for irritation, Decaltal N (multikonstituenter Stoff) does not show an eye irritating potential under the test conditions chosen.