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Description of key information

Skin corrosion: Not corrosive in absence of skin and eye irritation

Skin irritation: not irritating

Eye irritation: not irritating

Respiratory irritation (in absence of human data and skin and eye irritation): not irritating

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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test conducted prior to the GLP guidelines.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: FDA of the United States
Version / remarks:
FDA of the United States (Fed. Reg .28 (119), 5582 1963)
Qualifier:
according to guideline
Guideline:
other: Draize and Kelley
Version / remarks:
Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)
GLP compliance:
no
Remarks:
Test conducted priro to the GLP guidelines
Specific details on test material used for the study:
Clear colorless liquid designed Dihydromyrcenylacetate (Institute's code: DHMA) was received on 19th Januray, 1979.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Twelve healthy adult albino rabbits are used
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of undiluted the test substance is brought on the skin
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
Six rabbits are treated on the intact skin and Six others on the abraded skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, also animal 8959 and 8960
Remarks:
24 and 72 hours were scored
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, also animal 8961
Remarks:
24 and 72 hours were scored
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, 1 animal
Remarks:
24 and 72 hours were scored
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, 5 animals; 5857, 8959, 8960, and 8961
Remarks:
24 and 72 hours were scored
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, 1 animal
Remarks:
24 and 72 hours were scored
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: 1 animal
Remarks:
24 and 72 hours were scored

After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema.

After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness.

There were no disctinct differences between reactions of the intact and those of the abraded skin. From these results it appear that DHMA is a moderate primary skin irritant.

Interpretation of results:
other: Not a skin irritant.
Remarks:
According to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The substance is not a skin irritant in the OECD TG 404 using EU CLP criteria, but it is classified Category 3 (mild irritant) based on GHS criteria.
Executive summary:

The substance was examined for primary skin irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods somewhat similar to OECD TG 404. Six rabbits, previously clipped on the backs, are treated on the intact skin and Six others on the abraded skin with 0.5 ml of the undiluted test material. After an exposure of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours application). After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema. After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness. There were no disctinct differences between reactions of the intact and those of the abraded skin.

From the results of the present study it can be concluded that the substance irritation seen is insufficient for being a skin irritant.

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 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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test conducted prior to the GLP guidelines
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: FDA of the United States
Version / remarks:
FDA of the United States (Fed. Reg .28 (119), 5582 1963)
Qualifier:
according to guideline
Guideline:
other: Draize and Kelley
Version / remarks:
Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)
GLP compliance:
no
Remarks:
Test conducted prior to the GLP guidelines
Specific details on test material used for the study:
Clear colorless liquid designed Dihydromyrcenylacetate (Institute's code: DHMA) was received on 19th Januray, 1979.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six New Zealand White albino rabbits are used for each test substance. The animals are cages individually and receive no hay or other extraneous materials that might enter the eyes.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10 ml of undiluted test material
Duration of treatment / exposure:
instillation
Observation period (in vivo):
The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.
Duration of post- treatment incubation (in vitro):
none
Number of animals or in vitro replicates:
Six New Zealand White albino rabbits
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hours scored
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
mean of 2 animals
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hours scored
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
2
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
2
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hours scored
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals and only 24 and 48 hr scored
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
Mean of 2 animals
Irritant / corrosive response data:
DHMA caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up.

An animal is considered as giving a positive reaction if there is, at any of the reading, discernible opacity of the cornea or inflammation of the iris (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection) or if such susbtance produces in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with the partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA scoring scale is used.

Interpretation of results:
other: not an eye irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.
Executive summary:

The substance was examined for eye irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods, somewhat similar to OECD TG 405. The eyes of animals are examined before testing and only those animals without observable eye defects are used. One tenth of milliliter of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent the loss of material. The eyes are not washed following instillation and the animals are released immediately. The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance 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 substance was examined for primary skin irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods somewhat similar to OECD TG 404. Six rabbits, previously clipped on the backs, are treated on the intact skin and Six others on the abraded skin with 0.5 ml of the undiluted test material. After an exposure of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours application). After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema. After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness. There were no disctinct differences between reactions of the intact and those of the abraded skin.

From the results of the present study it can be concluded that the substance irritation seen is insufficient for being a skin irritant.

Eye irritation

The substance was examined for eye irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods, somewhat similar to OECD TG 405. The eyes of animals are examined before testing and only those animals without observable eye defects are used. One tenth of milliliter of the test substance is allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing to prevent the loss of material. The eyes are not washed following instillation and the animals are released immediately. The substance caused slight conjunctivitis in one out of six rabbits. After 48 hours the eye effects has cleared up. Therefore the substance is not considered to be an eye irritant.

Respiratory irritation

There are no occupational or consumer data indicating respiratory tract irritation. There are also no relevant experimental guidelines or results available that indicate respiratory irritation, therefore respiratory irritation is not anticipated. The substance is also not a skin irritant and not an eye irritant and therefore there is no indication for respiratory irritation.

Justification for classification or non-classification

Based on the results, the substance does not need to be classified for skin corrosion, irritation, eye or respiratory irritation according to EU CLP (EC No. 1272/2008 and its amendments).