Hexanoic acid, 3,5,5-trimethyl-, tin(2+) salt (2:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-04-05 to 2011-04-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

tin(2+) bis(3,5,5-trimethylhexanoate)

EC Number:

700-567-0

Cas Number:

1231728-34-9

Molecular formula:

C18H34O4Sn

IUPAC Name:

tin(2+) bis(3,5,5-trimethylhexanoate)

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Kissleg, Germany
- Age at study initiation: no data
- Weight at study initiation: 1968.0 g, 1832.4 g and 2054.8 g
- Housing: housed single in steel cages with a plastic bottom mould
- Diet (e.g. ad libitum): ad libitum Altromin 2023 Maintenance diet for rabbits
- Water (e.g. ad libitum): tap water from municipal source ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): dimmed day light

IN-LIFE DATES: From: To: 2011-03-29 to 2011-04-26

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye remained untreated and served as a control.

Amount / concentration applied:

0.1 mL of the test substance was applied by means of a syringe to the eye of the animals.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes have not been rinsed.
- Time after start of exposure: -

SCORING SYSTEM: According to OECD guideline 405, (Draize system)

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein (Fluorescein sodium C.1. 45350, Merck KGaA, Darmstadt, Germany, Batch No. K 38004887 746, durable till 2013-02-28) to look for damage of the cornea. One drop of a 0.5 % (w/v) fluorescein solution in saline was poured into both eyes and washed off with saline solution 30 seconds later. Afterwards scoring was carried out by use of an UV-Iight lamp. This procedure was repeated at all observation time points until day 14.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24,48 and 72 hours

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24,48 and 72 hours

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 21 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24,48 and 72 hours

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #3

Time point:

other: mean 24,48 and 72 hours

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean 24,48 and 72 hours

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

Moderate to strong ocular reactions including iris irritation and cornea damage were observed within 24 hour following application of 0.1 ml of the
test substance to the eyes. In all animals cornea damage, iris irritation and irritating effects to the conjunctivae were irreversible within 21 days.

Other effects:

Symptoms of systemic toxicity caused by the test substance were not observed during the whole study.
Body weight gain was positive and within normal range.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time

 

Score at time point / Reversibility	Cornea	Iris	Conjunctivae Redness	Conjunctivae Chemosis	Conjunctivae Discharge
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4	Max.score: 3
1 h	0/0/0	1/0/1	1/2/2	1/1/1	2/2/2
24 hours	4/4/4	1/1/1	2/2/2	3/2/3	2/2/2
48 hours	4/4/4	1/1/1	2/2/2	2/2/2	2/2/2
72 hours	4/4/4	1/1/1	2/2/2	2/1/2	2/2/2
Day 7	4/4/4	1/1/1	2/2/2	1/1/2	1/1/1
Day 14	4/4/4	1/1/1	1/1/2	1/1/1	1/1/1
Day 21	2/2/2	1/1/1	1/1/1	1/1/1	0/0/0
Average 24h, 48h, 72h	4/4/4	1/1/1	2/2/2	2.33/1.67/2.33	2/2/2
Area effected (Average 24h, 48h, 72h)	4/4/4
Reversibility	not	not	not	not	not

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

Interpretation is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility. Moderate to strong effects were observed in all three animals. Cornea damage, iris irritation and slight irritation of the conjunctivae persisted until study termination (day 21 p.a.) in all animals.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405 (2002) 0.1 mL of hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) was instilled into the conjunctival sac of three White New Zealand rabbits. The eyes were not rinsed after substance application. Animals then were observed for 21 days. Irritation was scored by the method of Draize. At 24, 48, 72 hours as well as 7 and 14 days post application the eyes were further examined with fluorescein to look for cornea damage.

 

All 3 animals showed moderate ocular reactions 1 h after application of the test substance.

24 h, 48 hand 72 h after application moderate to strong ocular reactions were observed in all three animals. In addition all rabbits showed irritation of the iris (score 1). Opaque cornea (score 4) over the whole area was observed in all animals 24 h, 48 hand 72 h after application.

Cornea damage, iris irritation and slight irritation of the conjunctivae persisted until study termination (day 21 p.a.) in all animals.