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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
21/10/2004-23/01/2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in complikance with GLP. The study is a read across from citric acid (CAS 77-92-9).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): citric acid

- Physical state: white crystalline solid

- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River (UK) Ltd, Margate, Kent, UK

- Age at study initiation: 8-12 weeks

- Weight at study initiation: minimum 200g

- Housing: solid-floor polypropylene cages furnished with woodflakes. Individually housed during the exposure nperiod and in groups of five, by sex, for the remainder of the study.

- Diet: Certified rat and mouse diet (code 5LF2), ad libitum

- Water: mains drinking water, ad libitum

- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS

- Temperature (°C): 19-25

- Humidity (%): 30-70

- Air changes (per hr): minimum 15

- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: the back

- % coverage: 10%

- Type of wrap if used: surgical gauze, semi-occluded with a piece of self-adhesive bandage.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): the bandage was removed after the exposure period, and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.

- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg

- For solids, paste formed: no. The appropriate amount of test material, moistened with distilled water, was applied as evenly as possible

Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5M,5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed for deaths and overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing. Individual bopdy weights were recorded prior to application of the test material on day 0 and on days 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The gross necropsy consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected bodyweight gains during the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value of >2000mg/kg was determined in a reliable study conducted according to an appropriate test protocol.