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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 186
Time point:
other: 24 hours
Score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 186
Time point:
other: 24 hours
Score:
2
Reversibility:
not fully reversible within: 7 days
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
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
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
Irritation parameter:
chemosis score
Basis:
animal: 188
Time point:
other: 24 hours
Score:
2
Reversibility:
not fully reversible within: 7 days
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
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
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
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
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
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.