Chromium trinitrate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: CrCl3, a structural analogue of chromic nitrate, can be used for read-across.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

no

Type of study:

guinea pig maximisation test

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

Albino guinea pigs weighing 300 and 500 Gm.

Route:

other: subcutaneous

Vehicle:

no data

Concentration / amount:

the sensitizing injections contained 0.5 cc of Freund's complete adjuvant with 0.5 cc of 3.4 × 10-2 M CrCl3. The test dose was 0.1 cc of 4.2 × 10-4 M CrC13 in physiologic saline intradermally

Route:

intradermal

Vehicle:

no data

Concentration / amount:

the sensitizing injections contained 0.5 cc of Freund's complete adjuvant with 0.5 cc of 3.4 × 10-2 M CrCl3. The test dose was 0.1 cc of 4.2 × 10-4 M CrC13 in physiologic saline intradermally

No. of animals per dose:

13: chromium chloride;
30: control group

Details on study design:

Thirteen guinea-pigs were given chromium trichloride hexahydrate by three subcutaneous injections in the nape 1 week apart. The sensitizing injections contained 0.5 ml of FCA with 0.5 ml of 3.4 × 10−2mol chromium chloride hexahydrate/l. Three weeks later, the animals were tested with an intradermal injection into clipped or epilated skin. The eliciting dose was 0.1 ml of 4.2 × 10−4 mol chromium chloride hexahydrate/l.

Challenge controls:

N/A

Positive control substance(s):

not specified

Positive control results:

N/A

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

4.2 × 10−4 mol

No. with + reactions:

10

Total no. in group:

13

Clinical observations:

developed positive reactions (at least +) ; of these, four were read as (+2). None developed (+3) or (+4) reactions.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 4.2 × 10−4 mol . No with. + reactions: 10.0. Total no. in groups: 13.0. Clinical observations: developed positive reactions (at least +) ; of these, four were read as (+2). None developed (+3) or (+4) reactions..

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results, chromium trichloride hexahydrate is a sensitizer to guinea pigs' skin at the 3.4 × 10−2 M under the conditions of this report.

Executive summary:

Thirteen guinea-pigs were given chromium trichloride hexahydrate by three subcutaneous injections in the nape 1 week apart. The sensitizing injections contained 0.5 ml of FCA with 0.5 ml of 3.4 × 10−2mol chromium chloride hexahydrate/l. Three weeks later, the animals were tested with an intradermal injection into clipped or epilated skin. The eliciting dose was 0.1 ml of 4.2 × 10-4 mol chromium chloride hexahydrate/l. After 48 h, this produced moderate positive responses in 10 of the 13 animals, whereas the control animals (injected only with FCA) showed no reactions. Of the 10 guinea-pigs sensitized to chromium chloride, 3 elicited weaker cross-reactions after intradermal injection of chromium nitrate (9.6 × 10-4 mol/l).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

No studies are available for chromium trinitrate but there were three studies available to evaluate the sensitization potential of chromium trichloride (CrCl3), a structural analogue of chromic nitrate, which can be used for read-across since there is no direct data on chromium trinitrate (Cr(NO3)3) and both compounds are very soluble chromium(III) compounds, whereas neither inorganic chloride nor nitrate salts are associated with skin or respiratory sensitisation..

Gross PR, Katz SA, Samitz MH (1968) exposed the 13 guinea-pigs to 0.5 ml of FCA with 0.5 ml of 3.4 × 10E−2 mol chromium chloride hexahydrate/L by three subcutaneous injections in the nape 1 week apart. Three weeks later, the animals were tested with an intradermal injection into clipped or epilated skin. The eliciting dose was 0.1 ml of 4.2 × 10E-4 mol chromium chloride hexahydrate/L. After 48 h, this produced moderate positive responses in 10 of the 13 animals, whereas the control animals (injected only with FCA) showed no reactions. Also, it showed that of the 10 guinea-pigs sensitized to chromium chloride, 3 elicited weaker cross-reactions after intradermal injection of chromium trinitrate (9.6 × 10E-4 mol/l).

Only one original article is available, which has been selected as a robust study summary, other two studies are summarized in a well-known publication (International Programme on Chemical Safety (IPCS) 2009). Both of them revealed positive reactions to chromium trichloride in guinea pigs, supporting the finding of Gross et al. above.

Based on the description given in these reports, chromium trichloride can be considered to be a sensitizer to guinea pigs' skin. Therefore, it is reasonable to assume that chromium trinitrate is a skin sensitizer too under the present conditions.

Migrated from Short description of key information:
Based on the results of chromium trichloride, chromium trinitrate can be considered to be a skin sensitizer in guinea pigs.

Justification for selection of skin sensitisation endpoint:
only one original article is available, other information was just summarized in the publication.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available results described in peer reviewed publications, chromium trinitrate can be classified as sub-category 1A for skin sensitisation according to CLP (Regulation EC No.1272/2008) respectively as a skin sensitizer Xi, R43 according to DSD (Directive 67/548/EEC).