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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 Oct 1996 - 4 Nov 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997
Reference Type:
secondary source
Title:
EPA High Production Volume Chemical Challenge Program CAS 141-17-3 adipic acid, bis[2-(2-butoxyethoxy)ethyl] ester
Author:
US EPA
Year:
2011
Bibliographic source:
High Production Volume Chemical Challenge Program

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Inc., Boyertown, PA, USA- Age at study initiation: approximately 6 - 9 weeks- Weight at study initiation: 222 - 254 g- Fasting period before study: 18 hours- Housing: stainless steel, indirect bedding- Diet: Lab Diet Certified Rodent Diet #5002, ad libitum- Water: ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 21 Oct 1996 - 4 Nov 1996

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
After 18 hours of fasting and prior to dosing, all rats (5 male: 5 female) were weighed and marked with ear clips. The weight variations of animals did not exceed ±20%. Individual doses were administered on the basis of body weight using a stainless steel intragastric feeding needle. Volumes of dose were 1.1 to 1.2 mL in all cases.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: animals were observed at 1, 3, 6 and 24 hours and daily thereafter for a total of 14 days.- Frequency of observations and weighing: at least once daily- Necropsy of survivors performed: complete gross necropsy performed on animals sacrificed at the end of the 14-day observation period. Sacrifice was accomplished via carbon dioxide asphyxiation.- Other examinations performed: animals were observed for signs of pharmacological activity and drug toxicity

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
A single male rat died by the 24 hour observation period.
Clinical signs:
Depression was noted in the single male animal that died. Slight depression was recorded in a single other male rat but this resolved by the 24 hour observation period. All other male rats appeared normal.Slight depression was noted in 3/5 female rats but these signs resolved by the 24 hour observation period.Red anal and urethral discharges were noted, with peri-anal hair loss. These signs resolved in all animals by observation Day 13.
Body weight:
Initial body weights:Males: 244 - 252 gFemales: 222 - 224Interim body weights (Day 7):Males: 289 - 313 gFemales: 242 - 258 gAll surviving animals gained weight.
Gross pathology:
In 3 female rats, a red discharge was noted around the nose. The small intestines appeared moderately reddened. The stomachs appeared ulcerated.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.