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EC number: 206-788-4
CAS number: 375-50-8
The registered substance was tested by the
oral and inhalation routes.
In a single key study, conducted according
to EC method B.1 and in compliance with GLP, no mortality was observed
at the oral limit dose of 2000 mg/kg bw in males and females. The main
clinical signs included reduced activity, and a hunched posture after
dosing, then ataxia at 24 hours.
By inhalation, in the selected key study
conducted according to OECD guideline 403 and EC method B.2, the LC50
was found to be above 23 mg/L (> 0.023 mg/m3 ; > 1238 ppm). No mortality
was observed at that dose but animals showed decreased activity until
day 5. At the next higher dose (2576 ppm ; 46.31 mg/L) , all animals
were comatose following the dosing (first day), then most animals showed
transient reduced activity and loss of reflex in the following days.
Some animals were sacrificed during the observation period due to severe
clinical signs. Another acute inhalation study was not used to determine
the LC50 due to some technical deficiencies, however, similar clinical
signs were observed, supporting GHS classification for narcotic effects.
A single key study, conducted according to OECD
402 and in compliance with GLP, no mortality was observed at the dermal
limit dose of 2000 mg/kg bw in males and females. No clinical signs and no
local skin reactions were noted during the study.
acute oral toxicity of the test substance was investigated in the albino
rat according to a protocol equivalent to OECD guideline 401 and in
compliance with good laboratory practices (GLP).
single dose of 2000 mg/kg (in Alembicol) was orally administered by
gavage to male and female rats (5/group and sex). Animals were observed
for a total of 14 days post-dose. Rats were then killed and subjected to
mortality occurred. Clinical signs observed after dosing included
ataxia, a hunched posture, reduced activity, mucoid faeces, skin/fur
staining, hair loss and piloerection. Changes in body weight were
unremarkable. Necropsy revealed no significant abnormalities.
Analytical concentration (ppm)
Died or killed in extremis
Day of death
6 (2 animals), 7 and 8
2, 3 and 8
3: Clinical observations immediately after exposure
Table 2: Mortality
Died or killed in extremis
3: Clinical observations immediately after exposure
Analytical concentrations (ppm)
Incidence in males
Incidence in females
Stains around nose
Breathing depth increased
Breathing rate decreased
Reduced foot withdrawal reflex
Palpebral reflex absent
Pinna reflex absent
Reduced righting reflex
Reduced response to sound
Decreased visual placement response
Increased response to touch
Abnormal respiratory noise
acute inhalation toxicity study was conducted according to OECD
guideline 403 and in compliance with good laboratory practices (GLP).
of five male and five female Alpk:APfSD (Wistar-derived) rats
were exposed nose-only for a single 4-hour period to a vapour of the
test substance at target concentrations of 50 ppm, 500, 1275, or 2500
ppm. Test atmospheres were analysed for vapour concentration. Following
exposure, the animals were retained without treatment for 14 days.
Clinical observations and body weights were recorded throughout the
study and at the end of the schedule period, the animals were killed and
given a gross examination post-mortem.
achieved test atmospheres had the following characteristics:
an exposure concentration of 2576 ppm, 4 males and 3 females died during
the maintenance period. Of the 3 surviving animals only 1 female
regained its initial body weight by day 15 of the study. There were a
number of clinical changes indicative of both respiratory irritation and
general toxicity including comatose state in all males and females on
the first day, reduced activity days 3 to 6 in most animals, loss of
reflex, which generally persisted until termination in one or more
animals. There were some minor macroscopic changes.
an exposure concentration of 1238 ppm, there were no mortalities. Two
females had exceeded their initial body weights by day 15 of the study
but the body weights of the remaining animals were equal to or below
their initial body weights by day 15 of the study. There were a number
of clinical changes indicative of both respiratory irritation and
general toxicity, including decreased activity (day 1 to 5) which had
resolved by day 12 of the maintenance period. There were no
compound-related macroscopic changes.
an exposure concentration of 613 ppm there were no mortalities. All
animals were gaining weight by day 15 of the study. There were minimal
clinical changes which had resolved by day 3 of the study and no
an exposure concentration of 63.5 ppm there were no mortalities, no
effects on body weight, minimal clinical changes which had resolved by
day 3 of the study and no macroscopic changes.
exposure for 4 hours to the test substance at a concentration of 1238
ppm resulted in no deaths. It was thus concluded that under the
conditions of this study the LC50 of the test substance was higher than
1238 ppm (23 mg/L) for male and female rats, therefore the test
substance does not meet the classification criteria of EC Regulation No.
1272/2008 (CLP / EU GHS) for acute inhalation toxicity.
dermal toxicity of 1,4-Diiodoperfluorobutane was investigated in
CRL:(WI) rats, in compliance with OECD Guideline No.: 402.
test was carried out at 2000 mg/kg body weight in both sexes (5
rats/sex). The test item was applied as supplied as a single dermal
24-hour exposure under a semi-occlusive dressing, followed
by a 14-day observation period.
observations were performed on all animals at 1 and 5 hours after dosing
and daily for 14 days thereafter. Body weight was measured prior to
dosing on Day 0 and on Days 7 and 14. Gross macroscopic examination
performed on all animals at the end of the 2-week observation period
no mortality during the study. No clinical signs and no local dermal
signs were observed after treatment with the test item or during the
14-day observation period. No effects were observed on body weights or
body weight gains in any animal during the study. There was no evidence
of abnormalities at necropsy.
dermal median lethal dose (LD50) of the test item
1,4-Diiodoperfluorobutane was found to be higher than 2000 mg/kg bw in
male and female Wistar rats.
Based on the results of good quality GLP
studies, and acute oral LD50 > 2000 mg/kg bw, an acute inhalation
LC50 > 20 mg/L, and an acute dermal LD50 > 2000 mg/kg bw the
substance is not classified for acute toxicity effects. However, based
on transient effects observed following administration of the high
doses, especially by inhalation, the substance is classified for
narcotic effects, STOT SE3, with the hazard phrase H336, May cause
drowsiness or dizziness.
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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