1-Octanol, reaction products with epichlorohydrin and 2-mercaptoethanol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study done according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions. Klimisch rating = 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

473-730-4

EC Name:

-

Cas Number:

928768-73-4

Molecular formula:

C13H28SO3

IUPAC Name:

1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol

Test material form:

aerosol dispenser: not specified

Remarks:

migrated information: aerosol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

Group 1:
Mean achieved atmosphere concentration: 0.90 mg/L
Mean mass median aerodynamic diameter (MMAD): 1.54 µm
Deaths: 0/3 male, 0/3 female.

Group 2:
Mean achieved atmosphere concentration: 4.73 mg/L
Mean mass median aerodynamic diameter (MMAD): 2.06 µm
Deaths: 1/3 male, 2/3 female.

Analytical verification of test atmosphere concentrations:

yes

Concentrations:

0.90 mg/L
4.73 mg/L

No. of animals per sex per dose:

3 males and 3 females per dose

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

4.73 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Sex:

male/female

Dose descriptor:

LC0

Effect level:

0.9 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No deaths in the 0,90 mg/L group.

Deaths: 1/3 male, 2/3 female in the 4,73 mg/L group. These animals were humanely killed due to the severity of the observations noted, these animals were considered unlikely to survive.

Clinical signs:

other: Common abnormalities noted during the study included increased respiratory rate or decreased respiratory rate, labored respiration, noisy respiration, hunched posture, pilo-erection, red/brown staining around the snout and wet fur. There were frequent ins

Body weight:

Group 1 - All animals exhibited body weight losses on Day 1 post-exposure. With the exeption of one female which showed a further body weight loss from Days 1 to 3 post-exposure, all animals exhibited body weight gains during the remainder of the recovery period.
Group 2 - All animals exhibited body weight loss on Day 1 post-exposure. All surviving animals exhibited further body weight losses from Days 1 to 3. Body weight gains were noted for all surviving animals during the remainder of the recovery period.

Gross pathology:

No macroscopic abnormalities were detected amongst animals from Group 1 or from the surviving animals from Group 2.
The following macroscopic abnormalities were detected at necropsy in the animals from Group 2 that were humanely killed during the course of the study at necropsy:
Lungs: abnormally pale or pale patches;
Liver: dark;
Kidneys: dark;
Stomach - gaseous distention;
Small Intestine: gaseous distension;
Large Intestine: gaseous distension.
Due to the observations noted it is considered that the deaths noted during the study may have been mainly attributable to local toxicity.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No animals died in a group of six rats exposed to a mean achieved atmosphere concentration of 0.90 mg/L, where as three deaths occured at the mean achieved atmosphere concentration of 4.73 mg/L. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC59) of Dynol 360, in the RccHan(TM): WIST strain rat, was in the range >1-5 mg/L (Globally Harmonized Classification System - Category 4) and had a 4 hr LC50 cut-off value of 5 mg/L.

LC50 is found to be at 4,73 mg/m³ (4,73 µg/L) of mist in a acute toxicity test according to OECD guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method. Hence the test substance is classified as toxic category IV according to CLP.

Executive summary:

LC50 is found to be at 4,73 mg/m³ (4,73 µg/L) of mist in a acute toxicity test according to OECD guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method. Hence the test substance is classified as toxic category IV according to CLP.