2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 December - 21st December 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Di-n-butyltin bis (2-ethylhexylthioglycolate)

IUPAC Name:

Di-n-butyltin bis (2-ethylhexylthioglycolate)

Details on test material:

- Name of test material (as cited in study report): TK 11638
- Trade name: Irgastab T 22 M
- Substance type: Organotin
- Physical state: Liquid
- Identity of Main component: Di-n-butyltin bis (2-ethylhexylthioglycolate)
- Purity: 65 %
- Impurities (identity and concentrations): 35 % Mono-n-butyltin tris (2-ethylhexylthioglycolate)
- Purity test date: NDA

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: IVANOVAS GmbH, Med. Versuchstierzuchten, KG, D-7964 Kisslegg
- Age at study initiation: NDA
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 10%
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light


IN-LIFE DATES: From: 14 December 1981 To: 21 December 1981

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

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

VEHICLE: N/A

Duration of treatment / exposure:

Single dose.

Observation period (in vivo):

72 hours.

Number of animals or in vitro replicates:

3 male and 3 female rabbits.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits, the treated eye was flushed with 10 ml of physiological saline.
- Time after start of exposure: Approximately 30 seconds after treatment.


SCORING SYSTEM:
The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4, and 7 days were summed up and the sum divided by 5. This procedcure was carried out seperately for unrinsed (A) and rinsed (B) eyes respectively.

0 = none
0.1 - 10.9 = minimal
11.0 - 25.9 = slight
26.0 - 55.9 = moderate
56.0 - 84.0 = marked
above 84.0 = extreme

The ratio R = A : B indicates the effect of rinsing the eyes approximately 30 seconds after application of the compound.

0 - 0.9 = rising increased the effect of the compound
1.0 = no effect
1.1 - 1.5 = practically no effect
1.6 - 2.0 = little but no effect
2.1 - 4.0 = good effect
4.1 - 10.0 = very good effect
above 10.1 = actions of the compound practically abolished.


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 186

Time point:

other: 24 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

chemosis score

Basis:

animal: 186

Time point:

other: 24 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 187

Time point:

other: 24 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: score dropped to 1 on day 7 but was not fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 187

Time point:

other: 24 hours

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: score increased to 3 at the 72 hour observation, but dropped to 2 at the 4 day observation

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 188

Time point:

other: 24 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: score dropped to 1 on day 7 but was not fully reversible

Results 6

Irritation parameter:

chemosis score

Basis:

animal: 188

Time point:

other: 24 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 189

Time point:

other: 24 hours

Score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: scored dropped to 1 at the 4 day observation and was completely reversed (0) at the 7 day observation

Results 8

Irritation parameter:

chemosis score

Basis:

animal: 189

Time point:

other: 24 hours

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: the score increased to 2 at the 72 hour observation and remained at the same level until the end of the observation period

Results 9

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 190

Time point:

other: 24 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: the score dropped to 1 at the 48 hour observation but then rose to 2 at the 72 hour observation, the score dropped to 1 again at the 4 day observation and remained at this level until the end of the test

Results 10

Irritation parameter:

chemosis score

Basis:

animal: 190

Time point:

other: 24 hours

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: the score rose to 2 at the 72 hour observation and remained at this level until the end of the test

Results 11

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 191

Time point:

other: 24 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: the score dropped to 1 at the 48 hour observation but then rose to 2 at the 72 hour observation, the score dropped to 1 again at the 4 day observation and remained at this level until the end of the test

Results 12

Irritation parameter:

chemosis score

Basis:

animal: 191

Time point:

other: 24 hours

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: the score rose to 2 at the 72 hour observation and remained at this level until the end of the test

Irritant / corrosive response data:

Primary eye irritation in unrinsed eyes = 8.7
Primary eye irritation in rinsed eyes = 6.1

Other effects:

None reported.

Any other information on results incl. tables

Table 1: Calculation of the Primary Eye Irriatation Index

Time after exposure days	Mean Reaction Score
	Unrinsedeyes(A)			Rinsed eyes (B)
	cornea	iris	conjunc‑ tiva	cornea	iris	conjunc‑ tiva
1	0	0	9.3	0	0	6
2	0	0	8.7	0	0	4.7
3	0	0	10	0	0	8
4	0	0	8.7	0	0	6.7
7	0	0	6.7	0	0	5.3
subtotal	0	0	43.4	0	0	30.7
total              43.7				30.7

Table 2. Individual rabbit eye irritation scores for each observation period.

	24 hours						48 hours						72 hours						4 days						7 days
Eye Treatment	not rinsed			rinsed			not rinsed			rinsed			not rinsed			rinsed			not rinsed			rinsed			not rinsed			rinsed
Animal number	186	187	188	189	190	191	186	187	188	189	190	191	186	187	188	189	190	191	186	187	188	189	190	191	186	187	188	189	190	191
1. Cornea
A Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
B Area involved	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
a=AxBx5 (Max. 80	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Mean score cornea	0			0			0			0			0			0			0			0			0			0
2. Iris
	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
b=scorex5 (Max. 10)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Mean score iris	0			0			0			0			0			0			0			0			0			0
3. Conjuctiva
A Redness	2	2	2	2	2	2	2	2	2	2	1	1	2	2	2	2	2	2	2	2	2	1	1	1	2	1	1	0	1	1
B Chemosis	2	2	2	1	1	1	2	2	2	1	1	1	2	3	2	2	2	2	2	2	2	2	2	2	2	2	2	2	2	2
C Discharge	1	1	0	0	0	0	1	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0
cxA+B+Cx2 (Max. 20)	10	10	8	6	6	6	10	8	8	6	4	4	10	12	8	8	8	8	10	8	8	6	8	6	8	6	6	4	6	6
Mean score conjuctiva	9.3			6			8.7			4.7			10			8			8.7			6.7			6.7			5.3
Total reaction score	10	10	8	6	6	6	10	8	8	6	4	4	10	12	8	8	8	8	10	8	8	6	8	6	8	6	6	4	6	6
Group mean	9.3			6			8.7			4.7			10			8			8.7			6.7			6.7			5.3

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

TK 11'638 fulfilled the criteria for classification and labelling according to 67/548/EEC as the mean scores for chemosis in none rinsed eyes were 2. Therefore the test material should be classified as R36 Irritating to the eyes under the conditions of the test.

Executive summary:

The primary eye irritation of TK 11'638 on New Zealand White rabbits was examined in a method similar to OECD 405 and EU method B.5. The test material was found to be irritating to the eyes. Rinsing the eyes following instillation was of practically no effect. The test material was classified according to 67/548/EC as R36 - Irritating to the eyes, based upon the test results.