Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
from 2009-09-15 to 2009-10-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. For read-across justification see Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters
- Physical state: liquid

- Molecular formula (if other than submission substance): C20 H30 O4
- Molecular weight (if other than submission substance): 334.46
- Smiles notation (if other than submission substance): O=C(c1ccccc1C(=O)OCCCCCC)OCCCCCC

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 261.2 ± 11.3 g (mean weight males), 220.4 ± 4.3 g (mean weight females)
- Housing: Polycarbonate cages measuring 42.5x26.6x18 cam with stainless steel mesh lid and floor
- Diet (e.g. ad libitum): 4 RF 18 ad libitum, supplied by Mucedola S.r.l., Settimo Milanese (MI), Italy
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 25
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2009-09-28 To: 2009-10-13

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal surfaces of the trunk
- % coverage: 10 %
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encyrcling the trunk of the animal with a lenght of elastic adhesive bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, by gentle swabbing of the skin with cotton wool soaked with lukewarm water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Aliquots were weighed accordingly to the body weight of each animal measured prior to dosing, no further details mentioned
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and morbidity twice daily, clinical signs were recorded on dosing, approx. 1, 2 and 4 hours after dosing and daily thereafter, body weights were recorded on the day of allocation (day -1), days 1, 8 and 15 (day of necropsy)
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
no clinical signs were observed
Body weight:
body weight changes were within the expected range
Gross pathology:
At necropsy examination performed on all animals at termination of the study red areas (multiple) in the thymus were noted in a single male animal. In In addition, tip of tail missing was seen in one male. No abnormalities were found in the remaining animals. No abnormalities were observed on the treated site of any animal.
Other findings:
Damaged tail was nloted in a single animal prior to treatment on the day of dosing up to the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute toxicity of 1,2-benzenedicarboxylic acid, C6-10 alkyl esters was investigated following dermal administration of a single dose to the rat at 2000 mg/kg.
No mortality occurred following dosing and no signs of toxicity were observed.
These results indicated that the test item has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrated the LD50 to be greater than 2000 mg/kg.
Executive summary:

The acute toxicity of 1,2 -benzenedicarboxylic acid, C6 -10 alkyl esters was investigated following dermal administration of a single dose to the rat at 2000 mg/kg according to OECD guideline 402, adopted on 24 February 1987 and Test method B.3 "Acute Toxicity (dermal)" described in Council Regulation (EC) No. 440/2008.

A single dose of 2000 mg/kg was administered to a group o 5 male and 5 female animals for 24 hours. After 14 days all animals were killed and subjected to necropsy examination. No mortality occurred following dosing and no signs of toxicity were observed. The body weight changes observed during the study were within the expected range for this species and age of animals. No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site. These results indicated that the test item has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrated the LD50 to be greater than 2000 mg/kg.