Registration Dossier

Administrative data

Description of key information

Based on the results of the study, C16 -18 and C18 -unsatd. TMAC is considered to be corrosive to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
other: Study was conducted equivalent or similar to OECD guideline 404.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Specific details on test material used for the study:
- Batch number: 73/222
- Physical state: Clear, slight-brown liquid
-Composition: TMAC: 50%, water: 15%, isopropyl alcohol: 35%
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL of undiluted test substance (50% pure)
Duration of treatment / exposure:
4 or 1 hour
Observation period:
4 or 1 hour, 48 hours 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: 4 hours
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:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
5.4
Max. score:
8
Reversibility:
not reversible
Remarks:
within 10 days
Remarks on result:
other: Study I, following exposure period of 4 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
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: 48 hours
Score:
1.25
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Study II, following exposure period of 1 hour
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
Interpretation of results:
other: Category 1C based on CLP criteria
Conclusions:
Under the test 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 guideline dermal irritation study was conducted on C16-18 and C18-unsatd. TMAC in rabbits. 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 hours. Observations were made at 4 hours, 48 hours and 10 days post-exposure. If the test substance appeared to be corrosive after 4 hours, another study was conducted with a 1 hour exposure period under similar test conditions. The Draize scoring criteria was used for evaluating the corrosion potential. At 4 hours, 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 hours, 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 hour, very slight erythema was observed with an average irritation score of 0.85/8. After 48 hours, 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 test conditions, the undiluted test substance (50% active ingredient) was not corrosive after 1 hour occlusive exposure and corrosive after 4 hours of occlusive exposure.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A dermal irritation study was conducted with the test substance, C16-C18 and C18 unsatd., TMAC, according to OECD equivalent Guideline 404. 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 d 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 edema 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 edema and the average irritation score was 5.4/8. After 10 d, 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 edema and the average irritation score was 1.25/8. No skin effects were observed after 10 d. Under the study conditions, the undiluted test substance (50% active ingredient) was not corrosive after 1 h occlusive exposure and corrosive after 4 h of occlusive exposure (van Beek, 1982).

Eye

Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation as the available information regarding skin irritation indicates the substance to be corrosive.


Justification for classification or non-classification

Skin

In a guideline equivalent in vivo skin irritation study, C16-18 and C18-unsatd. TMAC was corrosive to skin. The data justifies Skin Corr. 1C - H314: causes severe skin burns and eye damage according to CLP criteria (Regulation EC 1272/2008).

Eye

Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation as the available information regarding skin irritation indicates the substance to be corrosive.