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Description of key information

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:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
January to February 18, 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
KL2 due to RA
Justification for type of information:
Refer to the section 13 for details on the category justification.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.6 (Skin Sensitization)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: Kleinrusse Chbb
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HM/Fa. Thomae, Germany
- Average weight at study initiation: 2192 g
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
4 h
Observation period:
21 d
Number of animals:
5
Details on study design:
24 h before test start, the right flank of the rabbits was shaved and the skin inspected for intactness. Only rabbits with intact skin were used for the study. 0.5 mL of the undiluted test substance were applied to a 2.5 x 2.5 cm patch and placed onto the shaved skin, then securely fastened with a larger plastic sheet to provide an occlusive dressing. After 4 h, the dressing was removed and the skin was scored for reddening (erythema) and swelling (oedema) after 1, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d according to the Draize system.

Irritation parameter:
erythema score
Basis:
animal: 1-5
Time point:
24/48/72 h
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
erythema score
Basis:
animal: 1-5
Time point:
7 d
Score:
>= 1 - <= 4
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
erythema score
Basis:
animal: 1-5
Time point:
21 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
edema score
Basis:
animal: 1-5
Time point:
24/48/72 h
Score:
>= 1 - <= 4
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
edema score
Basis:
animal: 1-5
Time point:
7 d
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
edema score
Basis:
animal: 1-5
Time point:
21 d
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Irritant / corrosive response data:
Light to moderate erythema and light oedema were observed on the treated skin after removal of the patch. The reactions intensified until the 72 h observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 d. The acute reactions were no longer visible after 14 d.

None.

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the study conditions, the test substance was considered to be irritating to rabbit skin.
Executive summary:

A study was conducted to assess the skin irritation potential of the read across substance, C12-18 and C18-unsatd. DEA, to rabbit skin according to OECD Guideline 404 and EU Method B.6, in compliance with GLP. The shaved skin of 5 rabbits was exposed to the undiluted test substance using occlusive patches for 4 h. The skin was then observed for effects (scoring according to the Draize system) for 21 d after patch removal. Exposure to undiluted test substance caused light to moderate erythema and light oedema immediately after removal of the patch. The reactions intensified until the 72 h observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 d. The acute reactions were no longer visible after 14 d. Under the study conditions, the test substance was considered to be irritating to rabbit skin (Kästner, 1986). Based on the result of the read across study, the test substance is also expected to have similar skin irritation potential.

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:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
October 31, 1986 to November 25, 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
KL2 due to RA
Justification for type of information:
Refer to the section 13 for details on the category justification.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: Kleinrusse chbb
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- 4 males
- Source: HM/Fa. Thomae, Germany
- Average bodyweight at test start: 2,630 g
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.01 ml (low volume method)
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
4
Details on study design:
0.01 mL test substance carefully applied in undiluted form into the lower lid of the right eye of the test animals. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize appraisal method (J.H. Draize, Appraisal of the safety of chemicals in foods, drugs and cosmetics. Ass. of Food and Drug Officials of the US, pp 49-52 (1959)).
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.25
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.25
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2.58
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.17
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2.92
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period.

None.

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the study conditions, the test substance was highly irritating to the rabbit eye.
Executive summary:

A study was performed to assess the eye irritation potential of read across substance, C12-18 and C18-unsatd. DEA, according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. Four rabbits received 0.01 mL of an undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize scoring method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period. Under the study conditions, the test substance was highly irritating to the rabbit eye (Kästner, 1987). Based on the result of the read across study, the test substance is also expected to have similar eye irritation potential.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A study was conducted to assess the skin irritation potential of the read across substance, C12-18 and C18-unsatd. DEA, to rabbit skin according to OECD Guideline 404 and EU Method B.6, in compliance with GLP. The shaved skin of 5 rabbits was exposed to the undiluted test substance using occlusive patches for 4 h. The skin was then observed for effects (scoring according to the Draize system) for 21 d after patch removal. Exposure to undiluted test substance caused light to moderate erythema and light oedema immediately after removal of the patch. The reactions intensified until the 72 h observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 d. The acute reactions were no longer visible after 14 d. Under the study conditions, the test substance was considered to be irritating to rabbit skin (Kästner, 1986).

Eye

A study was performed to assess the eye irritation potential of read across substance, C12-18 and C18-unsatd. DEA, according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. Four rabbits received 0.01 mL of an undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize scoring method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period. Under the study conditions, the test substance was highly irritating to the rabbit eye (Kästner, 1987).

Justification for classification or non-classification

Skin

The key in vivo skin irritation study conducted with the read-across substance, C12-18 and C18-unsatd. DEA, demonstrated that a 4 h occlusive exposure was irritating to skin. On the basis of this study, the substance was classified as Skin Irrit. 2 - H315 (causes skin irritation) according to CLP (EC 1272/2008) criteria.

Eye

The key in vivo eye irritation study suggests that the read across substance, C12-18 and C18-unsatd. DEA, is highly irritating to eyes, with irreversible eye effects in one animal. Since the effects seen in this study were severe, the substance was classified as Eye Damage 1 - H318 (causes serious eye damage) according to CLP (EC 1272/2008) criteria.