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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD guideline with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
67359-57-3
EC Number:
614-052-2
Cas Number:
67359-57-3
IUPAC Name:
67359-57-3
Test material form:
liquid
Details on test material:
Chemical name: mixture of N,N-Dimethydecan-1-amide and N,N-Dimethyloctan-1-amide
Batch No: 903069
Storage: room temperature / in darkness
Vapor pressure: 0.01 kPa (at 25 °C)
Saturation cone.: 690 mg/m3 air (at 25 °C)
- Today handle under EC 909-125-3 Reaction mass of N,N-Dimethyldecan-1-amide and N,N-Dimethyloctan-1-amide.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann/ Borchen 7 District of Paderborn / Germany
- Age at study initiation: between 2-3 months old
- Weight at study initiation: The rats had a mean starting weight of approx. 170 to 210 g.
- Fasting period before study:
- Housing: Makrolon® cages type III, 5 animals per cage
- Diet (e.g. ad libitum): ad libitum ;"Altromin" 1324 Diet for Rats and Mice
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 4 days until the start of the treatment


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 2 °C
- Humidity (%): approx. 50 %
- Air changes (per hr): approx. 10 times per hour
- Photoperiod (hrs dark / hrs light): 12-hour artificial lighting from 06.00 to 18.00 hrs GET

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged for high concentration; mixture with polyethylene glycol 400 - ethanol for low concentrations
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The aerosol was sprayed under dynamic conditions into a cylindrical inhalation chamber with baffle
- Exposure chamber volume: The PVC inhalation chamber had the following dimensions: diameter = 30 cm, height = 28 cm (volume: approx. 20 liters)
- Source and rate of air/Method of conditioning air: The compressed air was produced with two in-parallel Boge compressors type SB 270/15/350D. The air was fully conditioned automatically by an in-line VIA compressed air dryer type A 110, i.e. water, dust and oil were removed.
- System of generating aerosols:The aerosol was generated by means of a nozzle (combination nozzle, Rhema Labortechnik Co.) and conditioned compressed air. A nominal 200 pi spray solution/10 liters air per min (dispersion pressure approx. 600 kPa) was nebulized under dynamic conditions into the baffle of the inhalation chamber.
- Method of particle size determination: Particle analysis was performed with an aerodynamic particle sizer with laser velocimeter (TSI-APS 3300)
- Treatment of exhaust air: outlet air was purified via a cotton wool filter
- Temperature, humidity, pressure in air chamber: temperature approx. 22 °C; relative air humidity approx. 30%


TEST ATMOSPHERE
- Brief description of analytical method used: Concentration in the test atmosphere was determined by gas chromatography (WL detector).
- Samples taken from breathing zone: yes


VEHICLE
- Composition of vehicle (if applicable):polyethylene glycol 400 (= PE) - ethanol mixture (mixing ration 1:1) for low concentrations
- Concentration of test material in vehicle (if applicable): approx. 10000 µL PE/m3 as an aerosol, approx. 10000 µL ethanol/m3 as a vapor)


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution/MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): see any other information

Analytical verification of test atmosphere concentrations:
yes
Remarks:
Concentration in the test atmosphere was determined by gas chromatography (WL detector)
Duration of exposure:
>= 4 h
Concentrations:
nominal: 1000; 5000; 20000; 50000 mg/m3
analytical: 118.5; 586.4; 2007.6; 3550.7 mg/m3
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 2 weeks post-treatment observation period
- Frequency of observations and weighing: Clinical signs - several times on day of exposure
- twice daily (mornig evening)
Rectal temperature - directly after exposure was completed
Body weights - before exposure; day 3 and 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, rectal temperature, necropsy
Statistics:
yes, different methods (Fisher's Pairwise Test, Box Test, ANOVA method etc)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 3 550.7 mg/m³ air (analytical)
Exp. duration:
4 h
Mortality:
No animals died up to and including a concentration of 20000 mg/m3 (nominal)
One male animal died on day 0 at a concentration of 50000 mg/m3 (nominal) all other animals survived the postobservation period
Clinical signs:
other: - 0mg/m3 and 1000mg/m3: All rats tolerated the treatment without clinical signs. - 5000mg/m3 Nose reddened, reduced motility, piloerection. All animals without signs from day 1 of the post-treatment observationperiod - 20000mg/m3 Rhinarium swollen, nose r
Body weight:
A toxicologically significant influence on body weights occurred during the post-treatment observation period from 20000 mg/m3 onwards.
Gross pathology:
Rats which died intercurrently; Lung distended, liver-like and edematous; hydrothorax; nose and rhinarium reddened and swollen; spleen pale; kidneys marbled; contents of duodenum slimy-yellow.
Rats sacrificed at the end of the post-treatment observation period; Gross pathological examination revealed no evidence of specific organ changes. In 50000µL/m3 "distended lung" tended to be more prevalent amongst the animals.
Other findings:
A toxicologically significant hypothermia was determined at the end of exposure from group 3 (5000 mg/m3 air)

Any other information on results incl. tables

ASSESSMENT AND DISCUSSION:

The test substance as an aerosol proved to have a relatively low acute inhalative toxicity in the rat up to the maximum tested concentration of 3551 mg/m3 air.

A single 4-hour exposure to 3551 mg/m3 air resulted in relatively persistent respiratory disorders considered to be causally related to a primary irritant effect on the respiratory tract. The hypothermia determined from 586.4 mg/m3 air is considered to be causally related to the aerosol's local irritant potential.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Acute inhaltion toxicity tested up to max attainable conc. Criteria used for interpretation of results: other: EU GHS EC 1272/2008
Conclusions:
LC50 inhalation (aerosol) Rat (exposure: 4 h) > 3551 mg/m3 air
Executive summary:

A study for acute inhalation toxicity was conducted with "confidential substance name" in accordance with OECD Guideline No. 403.

Therefore 5 SPF-bred Wistar rats were exposed (head/nose only) to 118.5; 586.4; 2007.6 and 3550.7 mg/m3 (analytical determined).

Rats subjected to a concentration of 119 mg/m3 air tolerated the exposure without signs occurring. Rats exposed to 586 mg/m3 air exhibited a transient reddening of the nose on the day of exposure and reduced motility. Rats subjected to the max. tested concentration (3551 mg/m3 air; nebulization of the undiluted test article) exhibited persistent signs causally linked to an irritation of the respiratory tract (slower breathing, serous nasal discharge, dyspnea, stridor, hypothermia). 3551 mg/m3 air was the range at which mortality started for male rats (1 of 5 died). The results of this study show that the respirable test article aerosol had a relatively low acute inhalative toxic effect on the rat. The acute potential hazard of the respiratory tract is attributed to the potency of the test substance aerosol to act as a mucosa irritant. LC50 inhalation (aerosol) Rat (exposure: 4 h) > 3551 mg/m3 air