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EC number: 249-828-6
CAS number: 29761-21-5
Acute oral toxicity:2 Weight of Evidence (WoE) tests: Acute toxic class method (no guideline followed): LD50 > 15800 and LD50 > 7940 mg/kg bw (male/female rat).Acute dermal toxicity:Standard acute method, Limit test (similar to OECD 402): LD50 > 2010 mg/kg bw (male/female rabbit).Acute inhalation toxicity:Standard acute method, Limit test (similar to OECD 403): LC0, 4h = 6.3 mg/L air (analytical) (aerosol; male/female rat).
The only 2 available studies for acute oral
toxicity of IDDPP were chosen as Weight of Evidence studies, as they
were concise, and not performed according to methods similar to an
existing guideline, but together provide sufficient information. In one
range finding study the undiluted compound was fed by stomach tube to
male and female rats (total 11 animals) in increasing doses (1000, 2000,
3160, 5010, 7940, 12600, and 15800 mg/kg bw). Toxic symptoms included
slight weakness in animals dosed at the two highest levels (12600 and
15800 mg/kg) for 3 to 4 days. No mortality occurred. The highest dose of
15800 mg/kg was found to be non-lethal in 5 rats, observed over a period
of 9 days. The oral LD50 of IDDPP is therefore > 15800 mg/kg bw in this
study. In the other, more recent, acute oral toxicity study the
undiluted compound was fed to 25 male and female rats (5 rats/dose) in
increasing doses (6310, 7940, 10000, 12600, and 15800 mg/kg).
Observations were made for toxic signs during 14 days, surviving animals
were sacrificed, and the viscera of the test animals were examined
macroscopically. Gross autopsy was performed on decedents. Signs of
intoxication were reduced appetite and activity (1 to 3 days in
survivors), increasing weakness, collapse, and death. Deaths were
observed at 10000 mg/kg (2 females), 12600 mg/kg (3 females), and 15800
mg/kg (2 females), at 1 to 4 days. Gross autopsy of decedents revealed
hemorrhagic areas of the lungs, liver hyperemia and gastrointestinal
inflammation. In survivors (14 days) the viscera appeared normal. Based
on mortality in the three highest doses, which was not sufficient to
derive an LD50 value, an LD50 of > 7940 mg/kg bw was set.
In the available key acute dermal
toxicity test of IDDPP was administered undiluted in a single dose of
2010 mg/kg on the lightly abraded skin of 5 male and 5 female rabbits,
and then occluded for 24 hours. The rabbits were observed during 14
days. There were no deaths during the study. The average skin erythema
and edema scores at 24 hours were 1.4 and 0.4 resp. The animals gained
weight in a normal manner. No observable abnormalities in any of the
animals at gross pathology examination. The acute dermal LD50 for IDDPP
as indicated by the data in this study is > 2010 mg/kg. One supporting
study, being a rather short abstract, was available for acute dermal
toxicity, not performed according to a method similar to an OECD
guideline. Two doses (5010 and 7940 mg/kg) were applied for 24 hours to
3 animals (2 (M+F) and 1 (M) per dose). Observations were made for toxic
signs during 14 days, surviving animals were sacrificed, and the viscera
of the test animals were examined macroscopically. No mortality
occurred. Signs of intoxication were reduced appetite and activity for 4
to 7 days. In the survivors (14 days) viscera appeared normal. The
dermal LD50 of IDDPP was established > 7940 mg/kg bw.
The key acute inhalation toxicity study in
rats was performed under early GLP. A single 4-hour exposure to 6.3 mg/L
IDDPP as a respirable aerosol mixture produced no mortality in a group
of 5 male and 5 female rats. Rats were observed for 14 days after
exposure. Signs exhibited during exposure included increases in
secretory responses and reduced activity. Signs during the post-exposure
period: incidences of secretory responses, rough coat and yellow
ano-genital fur. A transient decrease in body weight was observed. As no
deaths occurred the tested concentration can be considered as LC0 and
the LC50>6.3 mg/L. Two supporting studies were available, both performed
to a method similar to OECD 403, but not under GLP and with deviating
exposure times and number of animals tested. In one study 4 male rats
were exposed for 6 hours at the heated sample test (162.7 °C) of IDDPP
at a calculated concentration of 1.74 mg/l (vapour). All animals
survived the 6 hour exposure, but all succumbed in 3 to 4 days following
exposure. The LC100, 6h was calculated to be 1.74 mg/l (nominal
concentration). In the other supporting study a 1-hour acute inhalation
exposure to an aerosol of IDDPP at a nominal concentration of 100.2 mg/l
did not produce mortality in 5 male and 5 female rats, but caused slight
reversible irritation of the ocular, nasal, and buccal mucous membranes
in both sexes and slight residual pulmonary changes evident at necropsy
in males only. As no deaths occurred the tested concentration can be
considered as LC0(1h).
For acute oral toxicity, the LD50
value (for both male and female rats) was found to be at least > 7940
mg/kg bw in both WoE studies. Based on this value and the criteria
outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC, the
substance IDDPP does not need to be classified for acute oral toxicity.
For acute dermal toxicity, the LD50
value of > 2010 mg/kg bw (male/female rabbits, 24 h.) was used for
classification. Based on this value and the criteria outlined in Annex I
of 1272/2008/EC and Annex VI of 67/548/EEC, IDDPP does not need to be
classified for acute dermal toxicity.
For acute inhalation toxicity, the
LC50 value of > 6.3 mg/l for 6 h. was used for classification. Based on
this value and according to the EU criteria outlined in 67/548/EEC and
1272/2008/EC (CLP/EU-GHS) IDDPP does not need to be classified and has
no obligatory labelling requirement for inhalation toxicity.
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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