Registration Dossier

Toxicological information

Respiratory sensitisation

Currently viewing:

Administrative data

Endpoint:
respiratory sensitisation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study for which full study report available. Only a single exposure concentration was used but this was effectively the saturated vapour concentration. Exposure time was only 1 hou

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity of ethylene glycol mono-n-butyl ether in the guinea pig
Author:
Gingell R
Year:
1998
Bibliographic source:
Food Chem Toxicol 36 (9-10) 825-9

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CFR title 49, section 173.132
Deviations:
no
Principles of method if other than guideline:
Shorter test duration than OECD guideline
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material : ethylene glycol butyl ether
- Physical state: liquid
- Analytical purity: 99.87% (by GC/MS and NMR)
- Purity test date: 3-July-1994
- Lot/batch No.: 14MSH123
- Storage condition of test material: ambient
- Other: Source: Union Carbide, South Charleston

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP Inc, Denver
- Age at study initiation: 36 days
- Weight at study initiation: Males 400-472g, females 401-446g
- Housing: individual stainless steel mesh cages
- Diet ad libitum: AGWAY PROLAB animal diet guinea pig, except during exposure.
- Water ad libitum: tap, except during exposure
- Acclimation period: 8 days
- Other: animals prescreened for parasite infection.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-9-25C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12hr


IN-LIFE DATES: From: 9/3/94 To: 23/3/94

Test system

Route of induction exposure:
inhalation
Route of challenge exposure:
inhalation
Vehicle:
unchanged (no vehicle)
Concentration:
Calculated nominal: 1097ppm based on material consumed in vaporiser. This is the practical achievable vapour concentration.
Measured concentrations: 633 +/-14ppm for females, 691 +/-38ppm for males.
No. of animals per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: during exposure every 13mins. At 1-2 hours after exposure then daily.
- Necropsy of survivors performed: yes, after sacrifice using halothane.
- Other examinations performed: clinical signs, body weight,organ weights, complete necropsy.

Results and discussion

Results:
In this study, a single group of male and female guinea pigs was exposed to the maximum pratically achievable vapour concentration of 2 -butoxyethanol by whole body exposure for a period of 1 hour. This concentration was nominally 1097 ppm but the concentrations measured were 633ppm (3.1mg/l) for females and 691ppm (3.4mg/l) for males. The calculated saturated vapour pressure under ambient conditions is 791ppm. During exposure and the subsequent 14 day observation period, there were no deaths and no clinical signs of toxicity. No signs of irritation of respiratory tract were observed.

Mortality
no

Clinical signs
No signs of irritation of respiratory tract were observed.No adverse observations recorded.

Body weight
Weights measured at days 0, 7, 14. Whilst there was no control as a reference point, weight changes appeared to be normal and proportionate.

Gross pathology
Findings in majority of both sexes but not all: Hyperinflation of lungs (3 males), dark red discoloration (punctate foci) of all lung lobes (1 male), dark red discolouration of the liver (1 female), abnormal pink fluid in gall bladder (1 female). Also a traumatized liver (median lobe appeared torn) and evidence of haemorrhage in the peritoneal cavity (1 female.) All findings regarded as incidental. Hyperinflation common in guinea pigs due to holding of breath when in contact with anaesthetic gas.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
Since there were no deaths up to the maximum achievable vapour concentration and no signs of irritation of respiratory tract the substance would not be not sensitising for respiratory sensitisation by the inhalation route.
Executive summary:

In this study, a single group of male and female guinea pigs was exposed to the maximum pratically achievable vapour concentration of 2 -butoxyethanol by whole body exposure for a period of 1 hour.Nosigns of irritation of respiratory tract were observed.

This concentration was nominally 1097ppm but the concentrations measured were 633ppm (3.1mg/l) for females and 691ppm (3.4mg/l) for males. The calculated saturated vapour pressure under ambient conditions is 791ppm. During exposure and the subsequent 14 day observation period, there were no deaths and no clinical signs of toxicity.

 Progressive body weight gain was observed. No pathological findings attributed to exposure were seen.