Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A reliable study for skin irritation on citric acid 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.

A generally reliable study for eye irritation on citric acid, apparently conducted according to OECD 405 and GLP, reported that a 30% aqueous solution of the test substance caused well defined to moderate

conjunctival irritation that had not fully resolved after 14 days. A 10% solution was associated with weak to moderate conjunctival effects, resolved after 7 days. Given the 30% solution

effects would have been allowed to dissipate for 21 days, it is likely the test substance would not be considered irritating to the eyes according to EU criteria (please see attached expert

letter as reference).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 22 to 24 Feb 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: clipped: abraded and non-abraded
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
observed at 0, 20 and 44 h following 4-h exposure
Number of animals:
3
Details on study design:
Tested as 30% aqueous solution on intact and abraded skin under an occlusive covering. Examined at 0, 20 and 44 h following 4 -h exposure;. Current guidelines recommend
examination at 1, 24, 48 and 72 h, or until resolution of effects.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
(of all 3 animals)
Time point:
other: 0, 20, 44 h following 4-h exposure
Score:
0.8
Max. score:
8
Reversibility:
other: not fully reversible within: 44 h
Remarks on result:
probability of mild irritation
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
(of all 3 animals)
Time point:
other: 0, 20, 44 h following 4-h exposure
Score:
0
Max. score:
8
Remarks on result:
no indication of irritation
Other effects:
-

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
 Intact skin  Max. score: 4  Max. score: 4
 0 h   0/0/0   0/0/0
 20 h   0/0/0   0/0/0
 44 h   0/0/0   0/0/0
 Average 0 h, 20 h, 44 h     0
 Abraded skin    
0 h   1/1/2  1/1/1
 20 h  1/1/1  0/0/1
 44 h  1/1/1  0/0/1
  Average 0 h, 20 h, 44 h     1.7
 Intact and abraded skin: average 0, 20, 44 h     0.8
Interpretation of results:
GHS criteria not met
Conclusions:
A study conducted largely in accordance with OECD 404, but without GLP and using an occlusive dressing, found citric acid to be non-irritant to the intact skin of rabbits. The PII score of 0.8/8, reflecting effects in abraded skin, was said to indicate a material that would be classified as non-irritant. Current EC criteria would concur with this finding.
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from 22 to 24 Feb 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Potassium citrate salts are known to show a very high solubility in water and dissociate rapidly.
Potassium in known to be non-toxic. The toxicity is determined by the citrate moiety of the substance.
Because of that a read-across to citric acid is suitable for the determination of the toxicity.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: clipped: abraded and non-abraded
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
observed at 0, 20 and 44 h following 4-h exposure
Number of animals:
3
Details on study design:
Tested as 30% aqueous solution on intact and abraded skin under an occlusive covering. Examined at 0, 20 and 44 h following 4 -h exposure;. Current guidelines recommend
examination at 1, 24, 48 and 72 h, or until resolution of effects.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
(of all 3 animals)
Time point:
other: 0, 20, 44 h following 4-h exposure
Score:
0.8
Max. score:
8
Reversibility:
other: not fully reversible within: 44 h
Remarks on result:
probability of mild irritation
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
(of all 3 animals)
Time point:
other: 0, 20, 44 h following 4-h exposure
Score:
0
Max. score:
8
Remarks on result:
no indication of irritation
Other effects:
-

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
 Intact skin  Max. score: 4  Max. score: 4
 0 h   0/0/0   0/0/0
 20 h   0/0/0   0/0/0
 44 h   0/0/0   0/0/0
 Average 0 h, 20 h, 44 h     0
 Abraded skin    
0 h   1/1/2  1/1/1
 20 h  1/1/1  0/0/1
 44 h  1/1/1  0/0/1
  Average 0 h, 20 h, 44 h     1.7
 Intact and abraded skin: average 0, 20, 44 h     0.8
Interpretation of results:
GHS criteria not met
Conclusions:
A study conducted largely in accordance with OECD 404, but without GLP and using an occlusive dressing, found citric acid to be non-irritant to the intact skin of rabbits. The PII score of 0.8/8, reflecting effects in abraded skin, was said to indicate a material that would be classified as non-irritant. Current EC criteria would concur with this finding.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification