Registration Dossier

Administrative data

Description of key information

Based on the results from the in vivo irritation study, C16 -18 and C18 -unsatd. TMAC is considered to be corrosive to skin as well as eyes.

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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL of undiluted test substance (50% pure)
Duration of treatment / exposure:
4 or 1 h
Observation period:
4 or 1 hour, 48 h and 10 days
Number of animals:
Six males and females
Details on study design:
Six healthy adult New Zealand White albino rabbits (M/F) were used for the test. 24 hours prior to applying the test substance, the hair was removed from the back of the animals with electric clippers in such a way as to avoid abrasions.

An amount of 0.5 mL of the undiluted test substance was brought on the intact skin under a surgical patch measuring 1 x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.

Each rabbit was treated on the intact skin. The abrasions were minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.

After an exposure period of 4 or 1 hour the patches and the test substance applied were removed and the resulting skin reactions were evaluated by the method of Draize scoring. A second reading was made 48 hours later.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
ca. 0.85
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Study II, following exposure period of 1 hour
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 h
Score:
4
Max. score:
8
Reversibility:
not reversible
Remarks:
within 10 days
Remarks on result:
other: Study I, following exposure period of 4 hours
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 3.84
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: well-defined to moderate erythema
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 1.08
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: very slight to moderate erythema
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 10 dys
Remarks on result:
other: very slight to slight edema
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 1.58
Max. score:
4
Reversibility:
not fully reversible within: 10 days
Remarks on result:
other: very slight or slight edema
Irritation parameter:
overall irritation score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 5.4
Max. score:
8
Reversibility:
not reversible
Remarks:
within 10 days
Remarks on result:
other: Corrosive to skin
Irritation parameter:
overall irritation score
Remarks:
1 h exposure
Basis:
mean
Time point:
48 h
Score:
ca. 1.25
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: corrosive to skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Observations in 4 hours test:
- After 4 hours: Very slight to well-defined erythema, very slight ischemia and very slight edema
- After 48 hours: Well-defined to moderate erythema, very slight to slight ischemia and very slight or slight edema
- After 10 days: Slight to distinct incrustation and decreased hair growth

Observations in 1 h test:
After 1 h: Very slight erythema
After 48 h: Very slight to moderate erythema and very slight or slight edema
After 10 d: No skin effects were observed

For result tables, kindly refer to the attached background material section of the IUCLID.

Interpretation of results:
other: Category 1C based on CLP criteria
Conclusions:
Under the study conditions, the undiluted test substance (i.e., 50% active ingredient) was considered to be corrosive to the rabbit skin after 4 h of occlusive exposure.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance, C16 -18 and C18 -unsatd. TMAC (50% active) in rabbits, according to a method similar to OECD Guideline 204. Six rabbits (both sexes) were treated with 0.5 mL of undiluted test substance (50% active ingredient) in an occlusive patch fixed with adhesive tape and wrapped with an impervious material, for 4 h. Observations were made at 4 h, 48 h and 10 days post-exposure. If the test substance appeared to be corrosive after 4 h, another study was conducted with a 1 h exposure period under similar test conditions. The Draize scoring criteria was used for evaluating the corrosion potential. At 4 h, very slight to well-defined erythema, very slight ischemia and very slight oedema were observed, with an average irritation score of 4/8. At 48 h, there was well-defined to moderate erythema, very slight to slight ischemia and very slight or slight oedema and the average irritation score was 5.4/8. After 10 days, slight to distinct incrustation and decreased hair growth was observed. After an exposure period of 1 h, very slight erythema was observed with an average irritation score of 0.85/8. After 48 h, there was very slight to moderate erythema and very slight or slight oedema and the average irritation score was 1.25/8. No skin effects were observed after 10 days. Under the study conditions, the undiluted test substance (50% active ingredient) was corrosive after 4 h of occlusive exposure.

Endpoint:
skin corrosion: 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
Reason / purpose:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Reason / purpose:
data waiving: supporting information
Endpoint:
eye irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Reason / purpose:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A study was conducted to determine the skin irritation potential of the test substance, C16 -18 and C18 -unsatd. TMAC (50% active) in rabbits, according to a method similar to OECD Guideline 204. Six rabbits (both sexes) were treated with 0.5 mL of undiluted test substance (50% active ingredient) in an occlusive patch fixed with adhesive tape and wrapped with an impervious material, for 4 h. Observations were made at 4 h, 48 h and 10 days post-exposure. If the test substance appeared to be corrosive after 4 h, another study was conducted with a 1 h exposure period under similar test conditions. The Draize scoring criteria was used for evaluating the corrosion potential. At 4 h, very slight to well-defined erythema, very slight ischemia and very slight oedema were observed, with an average irritation score of 4/8. At 48 h, there was well-defined to moderate erythema, very slight to slight ischemia and very slight or slight oedema and the average irritation score was 5.4/8. After 10 days, slight to distinct incrustation and decreased hair growth was observed. After an exposure period of 1 h, very slight erythema was observed with an average irritation score of 0.85/8. After 48 h, there was very slight to moderate erythema and very slight or slight oedema and the average irritation score was 1.25/8. No skin effects were observed after 10 days. Under the study conditions, the undiluted test substance (50% active ingredient) was corrosive after 4 h of occlusive exposure.

Eye

In accordance with Annex VII, Section 8.2, Column 2, eye irritation studydoes not need to be conducted because the substance is classified as corrosive to the skin.


Justification for classification or non-classification

Based on the results of the in vivo skin irritation study, the test substance warrants a corrosive, 'Skin Corr. 1C; H314: Causes severe skin burns and eye damage' as well as serious eye damage, 'Eye dam. 1; H31: Causes serious eye damage' classification according to the EU CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint is covered by the above classifications for skin effects.