Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A 1968 non-GLP study report without guidelines specified. However, the report contains the essential elements for an acute dermal toxicity study and there were sufficient data reported to come to a conclusion. The level of information reported for systemic toxicity parameters was minimal.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Although no guideline appears to have been followed, the study was undertaken as a classical LD50 determination
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
EC Number:
271-090-9
EC Name:
1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
Cas Number:
68515-48-0
Molecular formula:
C26 H42 O4
IUPAC Name:
Not available, not a single isomer
Constituent 2
Reference substance name:
DINP
IUPAC Name:
DINP
Details on test material:
An organic ester; clear, slightly viscous liquid with an unpleasant odour received on 25 March 1968

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: Adult
- Weight at study initiation: 2.0-2.8 kg
- Fasting period before study: No evidence of fasting
- Housing: No data
- Diet (e.g. ad libitum): Purina rabbit chow. ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: Abdominal skin; no area reported
- % coverage: No data
- Type of wrap if used: Rubber dam binder wrapped with gauze and sticky tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 24 hours after exposure


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data-must have been variable volume dosage
- Concentration (if solution): 10% vol/vol or undiluted
- Constant volume or concentration used: constant concentration or undiluted

Duration of exposure:
24 hours
Doses:
50, 200, 754 and 3,160 mg/kg body weight
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Immediately, 1, 4 and 24 hours after dosing, and once daily thereafter. Bodyweights initially and terminally
- Necropsy of survivors performed: Yes
Statistics:
Not necessary

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
No deaths
Clinical signs:
No evidence of systemic toxicity at any dosage.
Body weight:
No data
Gross pathology:
No remarkable findings
Other findings:
Skin reactions generally consisted of moderate erythema at 24 hours, which diminished and completely subsided at all levels by Day 6, and slight desquamation in two to four animals, which disappeared by Day 12.

Any other information on results incl. tables

No tables or appendices on mortality, clinical signs, bodyweight or necropsy observations were reported. Dermal reactions at the application site are attached in the 'Overall remarks, and attachments' window below.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute dermal LD50 for rabbits of either sex was > 3160 mg/kg. Skin reactions generally consisted of moderate erythema at 24 hours which diminished and completely subsided at all levels by Day 6, and slight desquamation in two to four animals which disappeared by Day 12.
Executive summary:

In an acute dermal toxicity study, rabbits of either sex (New Zealand White) were given a single occluded dermal dose of MRD 68-28 in corn oil to the clipped abraded abdominal skin at nominal dosages of 50, 200, 754 or 3160 mg/kg. There were no deaths or no evidence of systemic toxicity observed during the subsequent 14-day observation period. Skin reactions generally consisted of moderate erythema at 24 hours which diminished and completely subsided at all levels by Day 6, and slight desquamation in two to four animals which disappeared by Day 12. Based on these results, the LD50 of MRD 68-28 was greater than 3160 mg/kg.

The toxicity study is considered acceptable for classification, and essentially satisfies the guideline requirements for rabbit acute dermal toxicity studies. The level of information reported for systemic toxicity parameters was minimal.