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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to 1500.41 in the Federal Register Vol. 38, No. 187, S. 26019 from 1973-09-27 with limited documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 1500.41 in the Federal Register Vol. 38, No. 187, S. 26019 from 1973-09-27
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Phosphorsaeure ca. 80 %ig (80 % phosphoric acid solution), 79/322
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: not applicable
- Isomers composition: not applicable
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.45-3.14 kg (mean: 2.79 kg)
- Housing: no data
- Diet: SSNIFF diet (Intermast), witheld during the contact period
- Water: withheld during the contact period
- 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: From: 1979-07-03 To: 1979-07-06

Test system

Type of coverage:
not specified
Preparation of test site:
other: all test sites were shaved, half of the test sites were abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 80 %

VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
24 hours
Observation period:
- Observations were performed at 24 and 72 hours and at 8 days post-dosing.
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: the test sites were covered with a rubberized covering (5 x 5 cm), fixed with bandaid strips, and wrapped with gauze.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM:
- The scoring system appears to be equivalent to the Draize scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(intact and abraded)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours post-dosing
Irritation parameter:
edema score
Remarks:
(intact)
Basis:
mean
Time point:
other: 24 hours
Score:
2.8
Max. score:
4
Reversibility:
not fully reversible within: 72 hours post-dosing
Remarks on result:
other: 1 score was 2, 5 scores were 3
Irritation parameter:
edema score
Remarks:
(intact)
Basis:
mean
Time point:
other: 72 hours
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours post-dosing
Remarks on result:
other: 4 scores were 2, 2 scores were 3
Irritation parameter:
edema score
Remarks:
(abraded)
Basis:
mean
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours post-dosing
Remarks on result:
other: all scores were 3
Irritation parameter:
edema score
Remarks:
(abraded)
Basis:
mean
Time point:
other: 72 hours
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 72 hours post-dosing
Remarks on result:
other: 5 scores were 2, 1 score was 3
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 72 hours
Score:
6.6
Irritant / corrosive response data:
Intact and Abraded Test Sites:
- In intact and abraded sites at 24 hours, edema and mild necrosis was observed in all animals.
- In intact sites at 72 hours, edema was observed in 3 animals and deep tissue necrosis was observed in the other 3 animals with gross pathological effects.
- In abraded sites at 72 hours, deep tissue necrosis was observed in all animals with accompanying edema in 1 animal. The necrosis was observed with gross pathological effects.
Other effects:
- All animals were sacrificed at 72 hours for humane reasons.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information 80% phosphoric acid Criteria used for interpretation of results: not specified
Conclusions:
The test substance was corrosive to the rabbit skin.