Registration Dossier

Administrative data

Description of key information

Skin irritation: Not irritating
Serious eye damage/eye irritation: Not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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: Basic information provided.
Reference:
Composition 0
Composition 0
Principles of method if other than guideline:
Sodium erythorbate powder (2000 mg/kg) was applied to the intact and abraded skin of six rabbits. Each test site was moistened with physiological saline just prior to dosing. After application of the test material, the exposure area was covered with a double layer of surgical gauze and a piece of rubber dam. The trunk of each rabbit was wrapped in a stockinette, which was secured to the body with tape. The dressings were removed after 24 hour, and the amount of residual sample and signs of localized irritation were noted. The exposure area was cleaned by thorough wiping, and the rabbits were observed for signs of toxicity for 48 and 72 hrs and 14 days.
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rabbit
Strain:
other: albino
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: test site was moistened with physiological saline
Controls:
not specified
Amount / concentration applied:
2000 mg/kg
Duration of treatment / exposure:
24 hrs
Observation period:
24hrs, 48hrs
Number of animals:
6
Irritation parameter:
erythema score
Basis:
animal: 5/6
Time point:
other: 24 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
animal: 1/6
Time point:
other: 24 hrs
Score:
1
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: 24 hrs
Score:
0
Irritant / corrosive response data:
A substantial amount of residual compound was observed 24 hours after dosing. No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight (1+) erythema at 24 hours that cleared by 48 hours (COLIPA 1982).
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lacton is not a dermal irritant.
Executive summary:

In a primary dermal irritation study, 6 rabbits were dermally exposed to 2000 mg/kg 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (test site moistened with physiological saline) to intact and abraded skin. Test sites were covered with an occlusive dressing for 24 hours.

No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight erythema at 24 hours that cleared by 48 hours. In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lacton is not a dermal irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic information provided.
Reference:
Composition 0
Composition 0
Principles of method if other than guideline:
Sodium erythorbate powder (100 mg) was instilled into the conjunctival sac of albino rabbits (10 male and 2 female). The eyes of half of the treated rabbits were rinsed after 5 seconds. Reactions were compared between rinsed and unrinsed eyes and the following irritation parameters were noted: iris, conjunctival redness.
GLP compliance:
not specified
Test material information:
Composition 1
Species:
rabbit
Strain:
other: albino
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Rinsed eyes: 5 Seconds
Unrinsed eyes: Continuous
Observation period (in vivo):
1hr, 24hr, 48hr
Number of animals or in vitro replicates:
12 (10 male, 2 female)
Irritation parameter:
other: Mean occular irritation score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 48 hrs
Score:
0.33
Irritation parameter:
other: Mean occular irritation score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 48 hrs
Score:
0.17
Irritant / corrosive response data:
Reactions were comparable in rinsed and unrinsed eyes, and were slight and transient in nature.

One hour after dosing, two of six unrinsed eyes had congestion of the iris, but the iris reacted normally to light. Varying degrees of redness were observed in the lids of all unrinsed eyes. Slight redness of the nictitating membrane or palpebral conjunctiva at the medial canthus was observed in two unrinsed eyes.

At one hour, 1+ iritis was observed in one rinsed eye. Five of six rinsed eyes had slight redness that was limited to only the nictitating membrane in three cases. At 24 hours, all eyes were normal, with the exception of one that had slight reddening of the conjunctiva at the medial canthus. All eyes, rinsed and unrinsed, were normal at 48 hours.

The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes) (COLIPA 1982).
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In a primary eye irritation study, 100 mg of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone powder was instilled into the conjunctival sac of albino rabbits (10 male and 2 female). The eyes of half of the treated rabbits were rinsed after 5 seconds. Animals were then observed for 2 days. Irritation was scored by the method of Draize.

One hour after dosing, two of six unrinsed eyes had congestion of the iris, but the iris reacted normally to light. Varying degrees of redness were observed in the lids of all unrinsed eyes. Slight redness of the nictitating membrane or palpebral conjunctiva at the medial canthus was observed in two unrinsed eyes.

At one hour, 1+ iritis was observed in one rinsed eye. Five of six rinsed eyes had slight redness that was limited to only the nictitating membrane in three cases. At 24 hours, all eyes were normal, with the exception of one that had slight reddening of the conjunctiva at the medial canthus. All eyes, rinsed and unrinsed, were normal at 48 hours. The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes).

In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone is not an eye irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

An in vivo skin irritation study (basic methodological details provided) was available. Animals were exposed (abraded and intact skin) under occlusive conditions for 24 hours. Skin reactions were evaluated at 24h, 48h and 72 hrs after exposure and no scoring scale was indicated. One rabbit (abraded skin) had slight erythema at 24 hours that cleared by 48 hours. Based on the results from the in vivo study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was classified as non- irritating. The results from this study are acceptable to use in the human health risk assessment.

Serious eye damage/eye irritation:

An in vitro eye irritation study was not required as an in vivo study was available. The in vivo study (basic methodological details provided) was conducted according to an older test method and six albino rabbits were used for each treatment (rinsed and unrinsed). The CLP regulation does not provide criteria for the evaluation of such studies. The current US EPA/UN Recommendations were considered as indicated in ‘Guidance on the application of the CLP criteria’, version 3.0, November 2012. Transient reactions (iritis, redness) were noted in unrinsed and rinsed eyes. All eyes, rinsed and unrinsed, were normal at 48 hours. The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110 (rinsed eyes). Based on these criteria, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone is not an eye irritant. The results from this study are acceptable to use in the human health risk assessment.


Justification for selection of skin irritation / corrosion endpoint:
Only 1 key study available

Justification for selection of eye irritation endpoint:
Only 1 key study available

Justification for classification or non-classification

Based on the available information in the dossier, the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) does not need to classified for skin irritation/corrosion and does not need to classified for serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.