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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:
From 2016-09-26 to 2016-10-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Sample from production lot
- Lot/batch No.of test material: Lab sample of October 9th 2015
- Expiration date of the lot/batch: 2016-10-08
- Purity: 99.91%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions
- Stability under test conditions: Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS srl, San Pietro al Natisone, Italy
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: Males: 253 - 274 g; Females 208 - 220 g
- Fasting period before study: No
- Housing: Individually caged
- Diet (e.g. ad libitum): Commercial rodent diet, ad libitum
- Water (e.g. ad libitum): Municipal supply tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 deg C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 15 20
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2016-09-26 To: 2016-10-11

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Approximately 5 x 7 cm
- % coverage: Approximately 10% of body surface
- Type of wrap if used: Elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
- Constant volume or concentration used: Yes, fixed concentration (100%)
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 Males / 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examined at least daily. Body weight determined weekly
- Necropsy of survivors performed: Yes
Statistics:
n/a

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
Systemic effects: None observed
Local effects: All animals showed fissuration and/or desquamation and/or scabs on the treated skin. Recovery has occurred by the end of the 14-day post-dose observation period
Body weight:
No treatment related effects
Gross pathology:
No abnormalities observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The lack of mortality demonstrates the LD50 to be greater than 5000mg/kg.
Executive summary:

The acute toxicity of THPA (tetrahydrophthalic anhydride) has been investigated following dermal administration of a single dose to the rat at a level of 5000mg/kg.

No mortality occurred following dosing and no clinical signs were noted indicative of systemic toxicity. Local (irritant) effects were observed, recovery occurring within 14 days.

The lack of mortality demonstrates the LD50 to be greater than 5000mg/kg.