Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Lack of details on test method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

lack of details on test method

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

EC Number:

203-749-3

EC Name:

(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine

Cas Number:

110-25-8

IUPAC Name:

N-methyl-N-oleoylglycine

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: yellow-brown viscous liquid
- Analytical purity: approximately 99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld, Germany
- Weight at study initiation: 187 g (males), 204 g (females)
- Diet: Herilan MRH (Eggersmann KG, Rinteln/Weser, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic head-nose apparatus (BUNDSCHUH, Griesheim, Germany) and constant infusion apperatus (UNITA I, BRAUN, Melsungen, Germany)
- Rate of air: 1000 L/h

TEST ATMOSPHERE
- Brief description of analytical method used: for the quantitative analysis an indirect indicator method was used. Therefore, the substance was mixed with 0.06 and 0.19% Oil Res 0 C.J. 26125. The samples were measured spectroscopically at 525 nm and the concentration of the test substance was evaluated using a calibration line.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0.3, 0.6, 2.2 and 3.7 mg/L (analytical concentration)
0.95, 1.67, 11.4 and 22.7 mg/L (nominal concentration)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for mortality and individual body weights were determined before start of the study and thereafter weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The statistical analysis was performed according to the "Probitanalyse" (D.J. Finney, 1971, Syndics of the Cambridge University Press, London, UK).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1.37 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Sex:

female

Dose descriptor:

LC50

Effect level:

1.8 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 3

Sex:

male

Dose descriptor:

LC50

Effect level:

1.05 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

0.6 mg/L: 3 males and 1 female animal died
2.2 mg/L: 10 males and 4 females died
3.7 mg/L: 8 males and 10 females died

Clinical signs:

other: 0.3 mg/L: flight attempts and gasping breathing 0.6 mg/L: additional to the signs of the low dose group and noisy breathing and slight staggering. One female showed lateral position. 2.2 mg/L: additional to the signs of the 0.6 mg/L dose group and bloody

Body weight:

2.2 mg/L (females): weight loss (mean 8 g) from Day 7-14
3.7 mg/L (males): weight loss (mean 4 g) from the Day of exposure to Day 7

Gross pathology:

Animals that died during the study period:
0.6 mg/L: heart: acute dilatation, acute hyperemia; lung: oedema with emphysema at the edges, pulmonary lobes were wet and fleshy and excess of blood were observed
2.2 mg/L: acute dilatation, acute hyperemia; lung: severe exhalation especially at the peripheral areas, severe oedema formation, single areas wet and fleshy. One animal with slight hydrothorax
3.7 mg/L: acute dilatation, acute hyperemia; lung: laminar bleedings, slight exhalation

Surviving animals:
Organs showed no signs of toxicity.

Any other information on results incl. tables

Table 1. Table for acute inhalation toxicity.

Target concentration [mg/L air]	Toxicological results*	Duration of clinical signs	Mortality (%)
Males
0.3	0/10/10	Day 2-7	0
0.6	3/10/10	Day 2-7	30
2.2	10/10/10	Day 2-7	100
3.7	8/10/10	Day 2-7	80
Females
0.3	0/10/10	Day 2-7	0
0.6	1/10/10	Day 2-7	10
2.2	4/10/10	Day 2-7	40
3.7	10/10/10	Day 2-7	100
LC50 = 1.37 (1.01-1.85) mg/L air

* first number = number of dead animals

 second number = number of animals with clinical signs

 third number = number of animals used

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Acute Inhal 4, H332
DSD: Xn, R20