Registration Dossier
Registration Dossier
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EC number: 201-069-1 | CAS number: 77-92-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted largely in accordance with the OECD guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- very minor deviations
- GLP compliance:
- yes
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- Molecular formula:
- C6H8O7
- IUPAC Name:
- 2-hydroxypropane-1,2,3-tricarboxylic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mohican Valley Rabbitry inc., Loudonville, OH, USA
- Age at study initiation: 5 months
- Weight at study initiation: 3.1-3.4 kg
- Housing: 1/suspended cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: duration not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-69 deg F
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: not stated
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: covered with patch moistened with water
- Controls:
- other: untreated skin serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g powder
VEHICLE
- Amount(s) applied: none - covered with wetted patch - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: not stated
- Type of wrap if used: wetted Webril patch held with Blenderm tape; covered with gauze bandage secured with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tepid water for 3 secs
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD 404/Draize; final score given as mean of 1, 24, 48 and 72 h readings
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 1, 24, 48, 72 h mean
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- other: very slight effects remaining at final observation at 72 h
- Remarks on result:
- other: mild skin irritant
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48, 72 h mean
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- other: very slight effects remaining at final observation at 72 h
- Remarks on result:
- other: not irritant according to EU criteria
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- slight indication of erythema at final observation at 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Well defined erythema in 1/6 from 1-48 h; mild erythema in the same animal was still evident at 72h when study was terminated. See table 1.
- Other effects:
- None reported.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema/eschar |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
2/0/0/0/0/0 |
0/0/0/0/0/0 |
24 h |
2/0/0/0/0/0 |
1/0/0/0/0/0 |
48 h |
2/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
1/0/0/0/0/0 |
0/0/0/0/0/0 |
Average given in report: 1h, 24h, 48h, 72h |
0.3 |
0 |
Average - EU criteria: 24h, 48h, 72h |
0.3 |
0 |
Reversibility* |
c |
n/a |
Average time for reversion |
unclear (likely to be reversible) |
|
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A reliable study conducted largely in accordance with OECD 404 and in compliance with GLP, found the citric acid to be mildly irritating to the skin of rabbits. Current EC criteria would find the material to be non-irritant.
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