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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Full study report available with detailed information on study. Not to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diethylene glycol monobutyl ether
- Physical state: liquid
- Analytical purity: >99.5%, confirmed by GC analysis
- Source: Texas Eastman
- Lot/batch No.: EK Acc#:902423. TEX#:56-21. PM#:1800. HS&HFL lab#:79-417

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory animals Inc, Denver, PA
- Age and weight at study initiation: no data
- Housing: metal cages
- Diet (e.g. ad libitum): Purina lab chow, ad libitum
- Water: ad libitum
- Acclimation period: 3 weeks


ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal
- % coverage: 3.5x4 inch area.
- Type of wrap if used: Pad in close contact with skin occluded with dental dam wrap. Substance injected under dam into pad then dam edges sealed with adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with cotton wool. No washing.
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
1701, 3402, 6804, 13608 mg/kg (based on 10.5, 21, 42, 84mmol/kg)
No. of animals per sex per dose:
5
Control animals:
other: no but other substances tested in same study acted as reference 'controls'
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Twice per day for mortality, once per day for abnormal signs. Body weights recorded before treatment and on days 7 & 14 (end of study).
- Necropsy of survivors performed: yes as well as animals that died.
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology
Statistics:
LD50 calculated using the method of Thompson and Weil (Biometrics 8, 51-4 (1952))

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 764 mg/kg bw
95% CL:
> 2 090 - < 3 645
Mortality:
None
Clinical signs:
At lower doses: anorexia, slight depression, cyanosis, ataxia, soft faeces. At higher doses: salivation, nasal discharge, iritis, significant depression, laboured breathing, prostration.
Body weight:
No adverse effects reported.
Gross pathology:
See table below
Other findings:
- Potential target organs: see table below

Any other information on results incl. tables

Summary of gross pathology:

Dose (mmol/kg)  10.5  21  42  84
Number of rabbits examined/with pathology  5/0  5/4  5/5  5/5
 Thymus - edatomous      2  
 Thymus - edema & Haemorrhage        3
 Thymus - increased vascularity      2  
 Yellow discoloration    3    
 Lungs - brown discoloration    2    
 Liver - brown discoloration    2    
 Kidneys - enlarged    1  1  
 Kidneys - discoloration (tan)    1    
 Kidneys - pelvis discoloration    2    
 Stomach - haemorrhage    3    
 Small intestines - increased vascularity      1  
 Urinary bladder - fluid, dark red    3    

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, this substance would not be classified for acute toxicity in accordance with the current EU guidelines.
Executive summary:

In a single 24 hour exposure dermal toxicity study, male NZ white rabbits were exposed to 2 -(2 -butoxyethoxy)ethanol. The LD50 value is shown below. Sub-lethal effects included at lower doses anorexia, slight depression, cyanosis, ataxia, soft faeces, and at higher doses salivation, nasal discharge, iritis, significant depression, llaboured breathing, and prostration.. Based on the results of this study, this substance would not be classified for acute toxicity in accordance with the current EU guidelines (Directive 67/548 or Regulation 1272/2008).

Results synopsis

LD50: 2764mg/kg