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EC number: 248-654-8
CAS number: 27776-01-8
Acute oral toxicity:Three studies are available for acute toxicity (2 GLP-compliant studies) of members of the diphenylmethane category. For SAS-40 the acute oral LD50 was estimated according to OECD guideline 401 to be 2531 mg/kg bw (GLP).For 1,1-DPE the acute LD50 was estimated according to OECD guideline 401 to be > 8000 mg/kg (GLP).For SAS-296 the acute oral LD50 was estimated in a non-GLP study similar to OECD 401.Acute toxicity via the inhalation route:For Phenyl-tolyl-ethane the LC50 was estimated in a GLP-compliant study according to OECD 403. A LC50 of 1-5 mg/l was determined.The acute toxicity of 1,1-DPE was assessed in a non GLP-compliant study according to OECD guideline 403. The determined LC50 was >1.6 mg/l.Acute dermal toxicity:For SAS-40 the acute dermal LD50 was estimated in a GLP-compliant study according to OECD 402 ro be > 2000 mg/kg bw.For SAS-305 the acute dermal LD50 was determined to be > 2000 mg/kg bw in a GLP-compliant study according to OECD guideline 402.For 1,1-DPE a GLP-compliant study according to OECD 402 is available. The dermal LD50 was estimated to be > 4 ml/kg.
A study was performed to determine the acute oral median lethal dose
(LD50) of the test material, administered undiluted, in the
Sprague-Dawley strain rat. The method used followed that described in
the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral
Toxicity" referenced as Method B1 in Annex V of EEC Commission Directive
84/449/EEC. Following a range-finding study, four groups, each of ten
fasted animals (five males and five females), were given a single oral
dose of undiluted test material at dose levels of 2324 to 5000 mg/kg
bodyweight. Deaths were noted one to four days after dosing. Common
signs of toxicity noted were hunched posture and pilo-erection.
Additional or isolated incidents of toxicity noted were ataxia,
lethargy, red/brown stains around the snout, red/brown stains around the
mouth, pallor of the extremities, loss of righting reflex, decreased
respiratory rate, ptosis, increased salivation, dehydration and
diuresis. Surviving animals appeared normal throughout the study or
three or four days after dosing. Incidents of reduced bodyweight gain
were noted during the study. Abnormalities noted at necropsy of animals
that died during the study were haemorrhagic or abnormally red lungs,
dark or pale liver or patchy pallor of the liver, pale spleen, pale
kidneys, haemorrhage of the glandular and non-glandular gastric
epithelia and haemorrhage of the small and large intestines. No
abnormalities were noted at necropsy of animals killed at the end of the
study except for pale livers noted in two females treated with 2324
The Mass Median Aerodynamic Diameter (MMAD) and geometric standard
deviation (gsd) were determined twice. For the 5 mg/L exposure group,
the MMAD was 2.9 μm (gsd 1.9) and 2.6 μm (gsd 2.1). For the 1 mg/L
exposure group, the MMAD was 2.8 μm (gsd 2.1) and 2.9 μm (gsd 1.9).
Phenyl-tolyl-ethane was administered as an aerosol by inhalation for 4
hours to two groups of five male and five female Wistar rats each group.
Animals were subjected to daily observations and determination of body
weights on Days 1, 2, 8 and 15. Macroscopic examination was performed on
the day of death or after terminal sacrifice (Day 15).
At 5 mg/L, on the day following exposure (Day 2) three males and two
females were found dead and the remaining animals were sacrificed for
ethical reasons. At 1 mg/L, one female was sacrificed for ethical
reasons on Day 2. No further mortality occurred. At 5 mg/L, the animals
showed gasping and laboured respiration during exposure. After exposure,
hunched posture, lethargy, flat posture, laboured respiration,
piloerection, ptosis and/or moribund status were shown by the animals.
At 1 mg/L, no clinical signs were noted during exposure. After exposure,
the animals showed lethargy, hunched posture, piloerection and/or ptosis
between Days 1 and 4. In addition, the female sacrificed on Day 2 showed
uncoordinated movements, chromodacryorrhoea, hypothermia, shallow
respiration and a lean appearance. At 5 mg/L, body weights loss was
noted in the animals found dead or sacrificed on Day 2. At 1 mg/L,
overall body weight gain and body weight loss in males and females was
within the range expected for rats of this strain and age used in this
type of study. At 5 mg/L, macroscopic post mortem examination of the
animals that were found dead or sacrificed for ethical reasons during
the study revealed abnormalities of the lungs (many dark red foci),
stomach (black foci in the glandular mucosa), liver (pale discoloration)
and mandibular lymph nodes (dark red discoloration). At 1 mg/L, no
abnormalities were found at macroscopic post mortem examination of the
animals. The inhalatory LC50, 4h value of Phenyl-tolyl-ethane in Wistar
rats was established to be within the range of 1 – 5 mg/L.
For category rationale and justification see attached category
documentation under section 13 "Assessment Reports".
A study was performed to assess the acute dermal toxicity of the test
material in the Sprague-Dawley strain rat. The method used followed that
described in the OECD Guidelines for Testing of Chemicals (1981) No. 402
"Acute Dermal Toxicity" referenced as Method B3 in Annex V of EEC
Commission Directive 84/449/EEC.
A group of ten animals (five males and five females), was given a
single, 24-hour, semi-occluded dermal application of the test material
to intact skin, at a dose level of 2000 mg/kg bodyweight.
There were no deaths. No evidence of systemic toxicity or skin
irritation were noted during the study.
All animals showed expected gain in bodyweight during the study period.
No abnormalities were noted at necropsy of animals killed at the end of
The acute dermal median lethal dose (LD50) of the test material in the
Sprague-Dawley strain rat was found to be greater than 2000 mg/kg body-
No data gaps were identified. The available data are adequate for risk
assessment and classification and labelling purposes.
Acute oral toxicity:
The respective criteria are not met.
The estimated LD50 of 2531 mg/kg bw. (read across from SAS-40) is well
above the treshold for hazard category 4 (2000 mg/kg bw). Benzyltoluene
is therefore not classified for acute oral toxicity.
Acute toxicity via the the inhalation route:
The respective criteria are met. The estimated LC50 of 1 - 5 mg/l (read
across from PTE) justifies the classification as acute toxic via the
inhalation route, category 4.
Acute dermal toxicity:
The estimated LD50 of > 2000 mg/kg bw. (read across from SAS-40) is
above the treshold for hazard category 4 (2000 mg/kg bw). Benzyltoluene
is therefore not classified for acute dermal toxicity.
detailed read across rationale and justification within the
diphenylmethane category see section 13, Read across document.
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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