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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
other: acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid and 2,2'-oxydiethanol
EC Number:
608-744-3
Molecular formula:
C12H14O6 C4H10O3
IUPAC Name:
Reaction mass of 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid and 2,2'-oxydiethanol
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Ester PSA + DEG (Additive 1132)
- Batch no. : P2D4000711
- Physical state: liquid
- Second Exp. Date: 2013-02-16
- Currenta Sample no.: 1439
- BTS internal sample no.: 111525

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
none: limit test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no clinical signs, no effects on weight development and gross pathological findings
Mortality:
none
Clinical signs:
other: none
Gross pathology:
no noticable gross pathological findings

Applicant's summary and conclusion

Executive summary:

An acute dermal toxicity study was performed according to OECD TG 402. 2000 mg/kg of the test item was applied semiocclusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and no gross pathological findings were observed during the 14 -days observation period. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.

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