Sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated)

Acute Toxicity: inhalation

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance Sorbitan monolaurate, ethoxylated, < 2.5 EO (CAS 9005-64-5). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9005-64-5

Cas Number:

9005-64-5

IUPAC Name:

9005-64-5

Details on test material:

- Name of test material: PC-2012-412
- Molecular formula: UVCB
- Physical state: yellow viscous liquid
- Analytical purity: 100%
- Batch No.: ES61C86614
- Expiration date of the batch: 05 January 2014
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

other: Crl:WI(Han) (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 271 g (males), 184 g (females)
- Housing: 5 animals per sex per cage in labelled Makrolon cages (type IV; height 18 cm)
- Diet (ad libitum, except during exposure): pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (ad libitum, except during exposure): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: design of the exposure chamber was based on a flow past nose-only inhalation chamber. The chamber consisted of three animal sections with eight animal ports each. Each animal port had its own atmosphere inlet and exhaust outlet. The main inlet of the test atmosphere was located at the top section and the main outlet was located at the bottom section.
- Method of holding animals in test chamber: animals were placed in restraining tubes and connected to the animal ports
- Source and rate of air: mean total airflow was 15.7 L/min
- System of generating particulates/aerosols: the test substance formulation was transferred to a nebulizer (type 950, Hospitak Inc., Lindenhurst, NY, USA) by means of a rotating pump (type VL500 digit, VERDER Lab Tec GmbH & Co. KG, Haan, Germany) and nebulized with the use of pressurized air. In order to nebulize the test substance, the viscosity of the test substance was reduced by heating up the test substance container, the nebulizer and pressurized air by means of water baths, set at a temperature of approximately 60°C. The primary aerosol was diluted with pressurized air and passed through the exposure chamber.
- Treatment of exhaust air: from the exposure chamber the test atmosphere was passed through a filter before it was released to the exhaust of the fume hood.
- Temperature, humidity: 21.7-22.2°C, 33-54%

TEST ATMOSPHERE
- Brief description of analytical method used: samples were drawn through a glass fiber filter. The collected amount of test substance in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter.
- Samples taken from breathing zone: samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of the middle section of the exposure chamber.

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: characterised twice during exposure. The samples were drawn (2 L/min) from the test atmosphere and collected with an 8 stage Marple personal cascade impactor containing fiber glass filters and a fiber glass back-up filter. Amounts of test substance collected were measured gravimetrically.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.2 µm / 2 µm (stage 1) and 2.3 µm / 2 µm (stage 2)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

4 h

Concentrations:

5.1 ± 0.1 mg/L (analytical)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During exposure, the animals were observed for mortality, behavioural signs of distress and effects on respiration 3 times and 1 and 3 hours after exposure. Afterwards they were observed once daily until day 15. Body weights were recorded on days 1, 2, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of systemic toxicity were noted up to the end of the 14-day observation period.

Body weight:

Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified