Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
immunotoxicity: acute oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on analytical purity of test substance otherwise sufficiently well reported to judge the results reliable with restrictions for use in risk assessment.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Comparative immunosuppression of various glycol ethers orally administered to Fischer 344 rats.
Author:
Smialowicz RJ, Williams WC, Riddle, MM et al
Year:
1992
Bibliographic source:
Fundam Appl Toxicol, 18(4), 621-7
Reference Type:
publication
Title:
The immunotoxicity of 2-methoxyethanol and its metabolites.
Author:
Smialowicz RJ
Year:
1996
Bibliographic source:
Occup Hyg, vol 2, p269-74

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats orally administered substance in two doses over a 2 day period then the humoral immune system functionality assessed with a T-dependent antigen response assay
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-methoxyethoxy)ethanol
EC Number:
203-906-6
EC Name:
2-(2-methoxyethoxy)ethanol
Cas Number:
111-77-3
Molecular formula:
C5H12O3
IUPAC Name:
2-(2-methoxyethoxy)ethanol
Details on test material:
-Source:Aldrich Chemical Company, Milwaukee, Mo
- Analytical purity:no data

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Source: Charles River Laboratory, Raleigh, NC
-Age at study initiation: 8-10 weeks
-Housing: 3 per polycarbonate cage, heat treated pine shavings bedding.
-Diet: Purina Lab Chow, Purina Mills, ad libitum
-Water: ad libitum

ENVIRONMENTAL CONDITIONS
-Temperature: 22C
-Humidity: 50-60%
-Photoperiod: 12hrs dark/12hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on exposure:
Preparation of dosing solution: no data
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
dosing volume 2.5ml/kg
Duration of treatment / exposure:
2 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 100, 200, 400mg/kg per day
Basis:

No. of animals per sex per dose:
6
Control animals:
yes, concurrent vehicle

Examinations

Humoral immunity examinations:
Method: Rats were immunized with a single intravenous injection of trinitrophenyl-Lipopolysaccharide (TNP-LPS) 2-4hrs prior to substance exposure. 3 days after final exposure, a splenic antibody plaque forming assay (PFC) using SRBC was carried out using the method of Smialowicz (Toxicology 44, 271, 1987).
Dose groups: See above
Number of animals: See above.
Statistics:
Results expressed as mean and standard deviation. Data analysed by one way analysis of variance with post analysis using Dunnett’s multiple comparison t-test or the Student-Newman-Kuels multiple range test as required. Significance level set at p<0.05.

Results and discussion

Results of examinations

Clinical signs:
not examined
Mortality:
not examined
Body weight and weight changes:
not examined
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Gross pathological findings:
not examined
Details on results:
Humoral immunity examinations: When expressed as cells/spleen, the 400mg/kg dose group showed a siginficant reduction but this was not evident in the 800mg/kg dose group, therefore the change in the 400mg/kg group was not regarded as biologically significant. No significant effects were seen in any of the other parameters assessed.

Specific immunotoxic examinations

Cell viabilities:
not examined
Humoral immunity examinations:
no effects observed
Specific cell-mediated immunity:
not examined
Non-specific cell-mediated immunity:
not examined
Other functional activity assays:
not examined
Other findings:
not examined

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 800 mg/kg bw/day
Sex:
male
Basis for effect level:
other: Humoral immunity markers

Applicant's summary and conclusion

Conclusions:
Substance has no significant effects on humoral immunity.
Executive summary:

Treatment of rats acutely with 2 -(2 -methoxyethoxy)ethanol causes no significant suppression of the antibody response to TNP-LPS at doses up to 800mg/kg.