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Diss Factsheets

Administrative data

Description of key information

Conflicting results were observed in 3 in vivo studies in rabbits. Depending on the formulation tested 2 tests (Bayer 1985 and Bayer 1984) were negative for skin corrosion, while one test showed corrosion (Bayer 1982). Therefore an in vitro test for skin corrosion was performed. The substance was tested in the EpiDerm™ Human Skin Model using duplicate tissues during 3 and 60 minutes. The relative mean viability of the test substance treated tissues was 17.4 % for the 3 minutes exposure and 9.5 % for the 60 minutes exposure. Therefore it can be concluded that the substance is corrosive to the skin (Category 1A).

Two in vivo tests for eye irritation showed that the formulations tested were severely eye damaging (Bayer 1982 and Bayer 1985).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 February 2017 to 23 February 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
2016
Qualifier:
according to guideline
Guideline:
other: Method B.40bis of Commission Regulation (EC) No 440/2008, of 30 May 2008,
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
other: EpiDerm™ Human Skin Mode
Cell source:
other: EpiDerm™ Human Skin Mode
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Human Skin Mode (MatTek)
- Tissue batch number(s):23395
- Delivery date: 22 February 2017
- Temperature used during treatment / exposure: 37 °C, 5% CO2
- Temperature of post-treatment incubation (if applicable): 37°C, 5% CO2

REMOVAL OF TEST MATERIAL AND CONTROLS: rinsed with PBS and blotted dry

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL MTT
- Incubation time: 3 h at 37 °C, 5% CO2
- Spectrophotometer: plate spectrophotometer using isopropanol as a blank.
- wavelength : 570 nm

TISSUES:
- Fresh tissues: for treatment, negative control and positive control
- N. of replicates : 2/treatment
- Method of calculation used:
TMT/UMT
TMT= test item treated viable
UMT = negative control viable

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 experiment

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50% (H314 1A), or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15% (H314 1B or 1C)
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15% (not classified as corrosive)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL as such

VEHICLE
- Amount(s) applied (volume or weight with unit): 50 µL distilled water

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8.0 N Potassium Hydroxide
Duration of treatment / exposure:
3 min and 60 min
Duration of post-treatment incubation (if applicable):
The plates was incubated (37 °C, 5% CO2) for 3 hours in presence of MTT. Thereafter tissues were placed in isopropanol for MTT extraction, which was measured in triplicate samples as optical density at 570 nm.
Number of replicates:
2/treatment
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
A 3 minutes exposure
Value:
17.4
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
corrosive
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
B 60 minutes exposure
Value:
9.5
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
corrosive
Other effects / acceptance of results:
The results were in agreement with the quality criteria:

Negative Control
The absolute OD562 of the negative control treated tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. The mean OD562 of the two negative control tissues should be ≥ 0.8 and ≤ 2.8 for each exposure time, which ensures that the tissue viability meets the acceptance criteria.
Positive Control
Potassium Hydroxide 8.0N solution is used as a positive control. An assay meets the acceptance criterion if mean relative tissue viability of the 60 minute positive control is < 15%.
Coefficient of Variation
In the range 20 and 100% viability, the Coefficient of Variation between tissue replicates should be ≤ 30%.

 

 

Exposure time

Mean OD570

Relative mean viability

Negative control

3 min

1.724

100%

 

60 min

1.607

100%

Test substance

3 min

0.300*

17.4%

 

60 min

0.153**

9.5%

Positive control

3 min

0.174*

10.1%

 

60 min

0.054**

3.4%

*Correction factor 0.043

** Correction factor 0.043

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
The substance is considered to be corrosive
Executive summary:

The substance was tested in the EpiDerm™ Human Skin Model using duplicate tissues during 3 and 60 minutes. As the substance is corrosive no additional controls were included for the observed color interference. The relative mean viability of the test substance treated tissues was 17.4 % for the 3 minutes exposure and 9.5 % for the 60 minutes exposure. Therefore it can be concluded that the substance is corrosive to the skin (Category 1A).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
9 November 1982 to 17 November 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lipischen Versuchtierzucht, Hagemann GmbH & Co KG, 4923 Exertal 1
- Weight at study initiation: average 2.5 kg
- Housing: individually
- Diet: SNIFF "mümmel z"(Soest, Westfalen) ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
NA
Observation period (in vivo):
after 1, 24, 48, 72 hours and on day 8
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein was applied after the 24 hour observation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
3.8
Max. score:
4
Reversibility:
not reversible
Remarks:
corneal opacity with keratoconus and starting maceration
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.9
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
severe irritant effects

Animal no

1

2

3

1

24

48

72

8

1

24

48

72

8

1

24

48

72

8

cornea

2

2

4

4

4

3

3

4

4

4

4

4

4

4

4

iris

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

chemosis

2

4

4

4

4

2

4

4

3

3

3

4

4

4

3

discharge

2

3

3

3

3

2

3

3

3

3

2

2

3

3

2

*not scored because of discolouration; corneal opacity with keratoconus and starting maceration (non-reversible)

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance as tested causes severe eye damage
Executive summary:

Three rabbits received 0.1 mL of the substance in their eye. Observations at 1, 24, 48 and 72 hours and after 7, 14 and 21 days showed irreversible effects on the cornea, iris and chemosis in all animals. All animals showed corneal opacity with keratoconus and starting maceration (non-reversible). Therefore it is concluded that the substance as tested causes serious eye damage (H318).

Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
October-November 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking and Curchill Ltd, Huntingdon/Interfauna UK Ltd
- Weight at study initiation: 3.0-3.3 kg
- Housing: individually in wire Type III cages
- Diet: SNIFF K4 (Versuchstieren Diäte, Soest, Westfalen) ad libitum
- Water: tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2 °C
- Humidity (%): 45-65%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
NA
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE: washed with physiological saline (after application of fluorescein)

SCORING SYSTEM: Draize

SCORING TIMES: at 1, 24, 48 and 72 hours and on day 7,14 and 21 after exposure
TOOL USED TO ASSESS SCORE: fluorescein applied after 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
increased to 3 on day 14 and 21
Irritation parameter:
cornea opacity score
Basis:
animal: 2 and 3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.8
Max. score:
3
Reversibility:
not reversible
Remarks:
in animal 1
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
in animal 1 and 3
Irritant / corrosive response data:
see table
Fluorescein staining in animal 1 showed damage of the cornea

Animal no

1

 

2

 

3

 

1

24

48

72

7

14

21

1

24

48

72

7

14

21

1

24

48

72

7

14

21

cornea

2

2

2

2

2

3

3

3

1

1

1

1

0

0

2

1

1

1

1

0

0

iris

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

0

1

1

1

1

1

0

1

1

1

1

1

0

0

1

1

1

1

1

1

0

chemosis

3

3

3

2

2

2

1

3

3

3

2

1

0

0

3

3

3

3

2

2

0

discharge

2

2

2

2

2

2

2

2

2

2

2

2

0

0

2

2

2

2

2

1

1

 

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance as tested is considered to induce irreversible effects on the eye
Executive summary:

Three rabbits received 0.1 mL of the substance in their eye. Observations at 1, 24, 48 and 72 hours and after 7, 14 and 21 days showed irreversible effects on the cornea and chemosis in one animal. Therefore it is concluded that the substance as tested causes serious eye damage (H318)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the information available the substance needs to be classified as corrosive (H314, category 1A) according to Regulation (EC) No 1907/2006.