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Administrative data

Description of key information

Skin corrosion: Substance is not skin and eye irritating and therefore also not corrosive.

Skin irritation (OECD TG 404): not irritating

Eye irritation (OECD TG 405): not irritating

Respiratory irritation: no adverse effects in absence of: human data indicating such. There is no concern because of absence of skin and eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
exposure period was 24 h instead of 4 h, observation time points were 0 and 48 h after patch removal instead of 24, 48 and 72 h
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or test system and environmental conditions:
No details provided
Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
with electric clipper, avoiding abrasions
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml testing material
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
12 animals - 6 with intact skin and 6 with abraded skin (results for abraded skin are disregarded).
Details on study design:
TEST SITE
- Area of exposure: 1x1 inch
- Type of wrap if used: surgical patch, fixed to application site with adhesive tape and entire trunk of rabbits is wrapped with impervious material.

OBSERVATION TIME POINTS
After 24 hours from the start of exposure (so directly after exposure, at time point 0 h after patch removal) and after 72 hours (so at time point 48 h after patch removal)

SCORING SYSTEM:
- Method of calculation: Draize (J. Pharmacol. 82 (1944) 377-390)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 0 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 0 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 0 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 0 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 0 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
other:
Remarks:
24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 hours and 72 hours timepoints were not scored
Irritant / corrosive response data:
The test substance caused moderate skin irritation. Its dermal effects observed after 24 hours of exposure (so at time point 0 h after patch removal) generally consisted of very slight to moderate erythema and very slight edema. Dermal effects observed after 72 hours after exposure (so at time point 48 h after patch removal) consisted of very slight or well-defined erythema, slight scaliness and very slight edema.

To be able to derive a CLP classification from skin irritation test results, normally the 24, 48 and 72 hours timepoints (after patch removal) for erythema and edema are used. In this study only the 48 hours timepoint is available for evaluation. As supporting evidence the reading directly after removal of the patch is available (0 hours timepoint), which can be considered the worst-case effect. Based on the available eythema and edema scores and given the longer exposure period (24 instead of 4 hours), it is concluded that classification for CLP purposes can be assessed with the current test as it can be seen as a worst-case.

Interpretation of results:
other: Not a skin irritant
Remarks:
Based on EU CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Hyacinth body was tested in a study similar to OECD TG 404 and based on the results it was concluded not to be a skin irritant.
Executive summary:

The skin irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD TG 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. In this study, 12 New Zealand white rabbits were used, 6 with intact skin and 6 with abraded skin. 24 hours prior to dosing the hair was removed from the back with a clipper. 0.5 mL testing material was applied on the skin under a surgical patch 1x1 inch. After the exposure period of 24 hours patches were removed. Only testing results of animals with intact skin were considered for evaluation of skin irritation. Observations made directly upon patch removal are treated as time point 0 h and the observations made at 48 hours after patch removal are treated as time point 48 h. The 24 h and 72 h time points were not scored, therefore the only 48 h results could be taken into consideration. Effects observed upon patch removal (so at time point 0 h) were limited. Slight to moderate erythema was observed (1 animal with score 3, 2 animals with score 2, 2 animals with score 1 and 1 animal with score 0) and none to slight edema (3 animals with score 1 and 3 animals with score 0). This was not sufficient to consider the substance a skin irritant. The decreased presence of dermal effects observed 48 hours after patch removal supports this finding. A slight to moderate erythema was then observed (1 animal scored 2 and 2 animals scored 1), none to slight edema (1 animal scored 1 and 5 animals scored 0) and a slight scaliness. Under the conditions of this test, some erythema and edema effects were observed directly after patch removal but only an erythema score for one animal was above the classification threshold. When taking the results from 48 h, though, none of the animals exceeded the score 2.3 for erythema or oedema (which is a criterion for EU CLP classification). Given the longer exposure period of 24 instead of 4 hours and the test results obtained, it can be concluded that Hyacinth body is not an irritant to skin.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No examination was done 1 hour after instillation, observation for 7 days.
GLP compliance:
no
Remarks:
pre-GLP
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: caged individually
- Other: the animals receive no hay or other extraneous material that might enter the eyes
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL testing material
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize and Kelley (1952)
The eyes of the animals were examined before testing and only those animals without observable eye defects were used.
The test material is allowed to fall on the everted lower lid of one eye of each rabbit and the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent loss of material.
The eyes were not washed following the installation and the animals were released immediately.
Irritation parameter:
cornea opacity score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 2 and 4
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 5 and 6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal: 2 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight redness of the conjunctivae in four out of six rabbits and slight swelling of the conjunctivae in one out of six rabbits were noted. After seven days all lesions cleared up.
Interpretation of results:
other: Not an eye irritant
Remarks:
Based on EU CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Under the conditions of this test (simialr to OECD TG 405), Hyacinth body is not considered to be an eye irritant.
Executive summary:

The eye irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD 405 but with (acceptable) deviations on the observation period and therefore a Klimisch 2 rating was assigned. In this study, 6 New Zealand white rabbits were used. Prior to instillation, eyes of the animals were examined for visible eye defects. 0.1 mL of testing material per animal was instilled in one eye and the other eye served as control. Eyes were not washed after instillation. Animals were observed at 24, 48, 72 and 7 days after instillation. No cornea and iris effects were noted. Slight redness of the conjunctivae in four out of six rabbits was seen (score 1 in 1 animal and score 0.66 in 3 animals; out of max. score 3), as well as a slight swelling of the conjunctivae in one out of six rabbits was noted (score 0.33 out of max. score 4). After seven days all lesions had cleared up. Under the conditions of this test, Hyacinth body is not considered to be an eye irritant.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

The skin irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD TG 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. In this study, 12 New Zealand white rabbits were used, 6 with intact skin and 6 with abraded skin. 24 hours prior to dosing the hair was removed from the back with a clipper. 0.5 mL testing material was applied on the skin under a surgical patch 1x1 inch. After the exposure period of 24 hours patches were removed. Only testing results of animals with intact skin were considered for evaluation of skin irritation. Observations made directly upon patch removal are treated as time point 0 h and the observations made at 48 hours after patch removal are treated as time point 48 h. The 24 h and 72 h time points were not scored, therefore the only 48 h results could be taken into consideration. Effects observed upon patch removal (so at time point 0 h) were limited. Slight to moderate erythema was observed (1 animal with score 3, 2 animals with score 2, 2 animals with score 1 and 1 animal with score 0) and none to slight edema (3 animals with score 1 and 3 animals with score 0). This was not sufficient to consider the substance a skin irritant. The decreased presence of dermal effects observed 48 hours after patch removal supports this finding. A slight to moderate erythema was then observed (1 animal scored 2 and 2 animals scored 1), none to slight edema (1 animal scored 1 and 5 animals scored 0) and a slight scaliness. Under the conditions of this test, some erythema and edema effects were observed directly after patch removal but only an erythema score for one animal was above the classification threshold. When taking the results from 48 h, though, none of the animals exceeded the score 2.3 for erythema or oedema (which is a criterion for EU CLP classification). Given the longer exposure period of 24 instead of 4 hours and the test results obtained, it can be concluded that Hyacinth body is not an irritant to skin.

Eye irritation

The eye irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD 405 but with (acceptable) deviations on the observation period and therefore a Klimisch 2 rating was assigned. In this study, 6 New Zealand white rabbits were used. Prior to instillation, eyes of the animals were examined for visible eye defects. 0.1 mL of testing material per animal was instilled in one eye and the other eye served as control. Eyes were not washed after instillation. Animals were observed at 24, 48, 72 and 7 days after instillation. No cornea and iris effects were noted. Slight redness of the conjunctivae in four out of six rabbits was seen (score 1 in 1 animal and score 0.66 in 3 animals; out of max. score 3), as well as a slight swelling of the conjunctivae in one out of six rabbits was noted (score 0.33 out of max. score 4). After seven days all lesions had cleared up. Under the conditions of this test, Hyacinth body is not considered to be an eye irritant.

Respiratory irritation

Respiratory irritation is not anticipated because there are no human data indicating such effects. In addition, the substance is not a skin or eye irritant under in vivo conditions, which further supports the absence of concern for respiratory irritation.

Justification for classification or non-classification

Based on the results of the skin and eye irritation tests it can be concluded that Hyacinth Body does not need to be classified as a skin, eye or respiratory irritant according to EU CLP (EC No. 1272/2008 and its amendments).