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EC number: 220-474-4
CAS number: 2778-42-9
study was conducted to evaluate the skin irritation of the test
substance. The study was performed according to a method equivalent or
similar to OECD Guideline 404, in compliance with GLP. The substance
(0.5 mL) was applied to the intact and abraded skin of rabbits via a 24
h occlusive patch. Scoring was done at 24 and 72 h and continued until
Day 13 post-dose. At the 24 and 72 h intervals, scores for erythema
ranged from very slight to severe for intact sites and from well-defined
to severe for abraded sites. Scores for edema ranged from none to slight
for both intact and abraded sites. There were no important differences
in skin irritation between intact and abraded sites. All animals
exhibited irritation at 72 h. By Day 6, all sites showed eschar
formation which persisted at all but 2 sites until termination. Under
the test conditions, the primary irritation index was calculated to be
3.3 and therefore the test substance was considered to be moderately
irritating to skin in rabbit (Knickerbocker, 1981).
study was conducted to evaluate the acute dermal toxicity and skin
irritation of the test substance according to a method equivalent or
similar to the OECD Guideline 404, in compliance with GLP. The substance
was applied at a dose of 2000 mg/kg bw topically to the abraded skin of
5 rabbits/sex via 24 h occlusive patches. All animals were observed
twice daily throughout the study and sacrificed on Day 15. A gross
post-mortem examination was performed and samples of the treated skin
were retained. One death occurred on Day 4 but no specific signs of
systemic toxicity were observed. The degree of dermal irritation was
scored with the Draize technique on Days 1, 2, 3, 4, 7 and 14. Mean
irritation score, maximum erythema score and edema score was 3.9/8,
3.9/4 and 0/4, respectively. Gross post-mortem examination revealed no
treatment-related significant effects. Under the test conditions, the
test substance was considered to be moderately irritating to skin in
rabbit (Koschier, 1981).
irritation (Draize) scores (mean)
Mean ocular irritation scores observed at 24, 48 and 72 h
* Eyes in three rabbits rinsed with sterile
water for 60 sec
study was conducted to evaluate the ocular toxicity of the test
substance in rabbits. The study was performed similar to the OECD
Guideline 405. 0.1 mL of the test substance was instilled into the right
eye of nine rabbits; the left eye served as an untreated control. One
group of six rabbits received no further treatment. In the second group
of three rabbits, eyes were rinsed 30 sec post-instillation for 60 sec.
Irritation was scored by Draize scoring system at 1, 2, 3, 4, 7, 10 and
13 d post-instillation. Mean irritation scores at 24, 48 and 72 h for
animals in group 1 (eyes without washing) were 0/0/2.6/3.3; 0/0/2.3/3.3;
0/0/1.67/3.3; 0/0/2.6/3.0; 0/0/2/3.0 and 0/0/2.67/3.67. Mean irritation
scores at 24, 48 and 72 h for animals in group 2 (eyes with washing)
were 0/0/1.67/2.67; 0/0/2/2 and 0/0/2/3.67. Irritation to the
conjunctivae appeared to dissipate but still persisted at the
termination of the study. Mean overall irritation score for 24, 48 and
72 h was 15.1/110 and 13.6/110 in the washed and unwashed eyes,
respectively (Chow, 1981).
study was conducted to evaluate the ocular toxicity of test substance in
rabbits. The study was performed equivalent or similar to OECD Guideline
405, in compliance with GLP. 0.1 mL of the test substance was instilled
into the right eye of each rabbit; the left eye served as an untreated
control. Eyes were rinsed 30 sec post-instillation and irritation was
scored by the Draize system at 1, 2, 3, 4, 7, 10 and 13 days
post-instillation. The overall irritation score was 18/110 and 15/110 in
the unrinsed and rinsed groups, respectively. Under the test conditions,
the test substance was considered to be mildly irritating to eyes in
rabbit (Koschier, 1981).
In studies conducted with rabbits,
m-TMXDI was irritating to skin, with irreversible erythema and oedema
observed in the test animals, as well as to eyes. Hence, it qualifies
for classification as Skin Irrit. 2 - H315 (causes skin irritation)
and Eye Irrit. 2 - H319 (causes serious eye irritation) according
to CLP (EC 1272/2008) criteria.
irritation was seen in rat and mouse studies, therefore
appropriate risk management measures and the use of personal protection
equipment are recommended to reduce exposure at the workplace.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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